Drugs and Pharmaceuticals

Industry

BDMA Proposes to Set Up an Environment Management Fund

The Bulk Drugs Manufacturers Association (BDMA) has called on the Department of Chemicals & Petrochemicals to set up an 'Environment Management Fund' to help the small and medium scale enterprises (SMEs) in the pharma sector. BDMA has suggested a pilot scheme of Rs. 1,000 crores during the 11th Five Year Plan period specifically targeted at States like Gujarat, Maharashtra, Andhra Pradesh and Punjab, where there is heavy concentration of bulk drug and pharmaceutical industries according to a note submitted to the Dept. The disbursement of the fund could be routed through State Industrial Infrastructure Development Corporations or Directorates of Industries, according to BDMA.

The BDMA said that though combined or common effluent treatment plants (CETPs) and treated toxic solvent disposal facilities (TSDFs) have been conceptualised and implemented, these mostly serve the larger manufacturing units which have their own primary and secondary treatment plants. "The SME sector is not able to invest in their captive primary and secondary treatment facilities like absorbers, forced circulation evaporators, incinerators spray dryers etc. Effluents and the solid wastes coming out of the primary and secondary treatments should be sent to CETPs for tertiary treatment and TSDFs”, the note said.

As per the Office of the Development Commissioner (SSI), contribution of SME sector in Indian pharma market is 50% by volume and 30% by value. The BDMA, in the comments on the draft Drugs Price Regulation and Control Act 2006, has asked the Government not to focus on prices as the drug prices are already very low in the country. BDMA has also asked for minimum investment norms for setting up API or a drug intermediate facility industry to ensure quality of medicines.

The association has called for enhanced focus on major leakages in healthcare costs such as hospitalisation charges, costs of diagnostics/ devices, expenditure involved in trade discounts/rebates etc and expenditure involved in influencing the prescribers. Price control is required only on imported drugs or patented drugs or new drugs where the number of formulation manufacturers very limited”, it said.

(Chemical Weekly, 16.1.2007, p. 136)

Drug Firms Express Displeasure Over Increase in Price Control Span

Domestic drug majors under the banner of Confederation of Indian Industry (CII), have approached Cabinet Secretary BK Chaturvedi for being allowed to present their views on the new pharmaceutical policy, scheduled to be discussed by the Union Cabinet.

The appeal, signed by Ranbaxy CEO Malvinder Singh and Nicholas Piramal Chairman Ajay Piramal, states that industry's recommendations to the 14-member review committee for the pharma policy "had been totally ignored by the ministry”. "There is no need to increase the span of drugs under price control. A short-term freeze on the price of controlled products and an efficient price monitoring regime thereafter would ensure the availability of affordable healthcare," it stated,

FICCI President Habil Khorakiwala has also written to Prime Minister Manmohan Singh on the issue. FICCI is apprehensive that industry may be forced to curtail the production of drugs because of unremunerative prices, this will result in inaccessibility of medicines for many consumers. Khorikawala, the chairman of Wockhardt Ltd said that the proposed policy would reinstitute the licence raj by introducing controls over the production, distribution and supply of drugs, even those not under price control.

The Indian Pharmaceutical Alliance (IPA), has blamed the ministry for pushing ahead a policy proposal against its interests. "Some of the policy proposals are inconsistent, arbitrary and open to litigation," said D G Shah, secretary general of IPA. The 74 drugs under current price control are based on the "economic" (market share and competition) criteria of the 1994 policy, whereas the 186 drugs now being brought under price control are based on the "essentiality" concept. The earlier 74 drugs will be allowed maximum allowable post manufacturing expense (MAPE) of only 100 per cent, whereas the new 186 drugs will get 150 per cent. The list of 186 drugs includes 45 from the earlier list, but they will be denied the higher rate of MAPE," he explained.

Even the Planning Commission has pointed out that "the most important part of the policy is to extend price control and expand the basket of controlled drugs from 74 at present to 354 drugs under the National List of Essential Medicines. Such a step could prove to be counter-productive as it would discourage new investment and limit competition. It might curtail profits and constrain research."

(Business Standard, 12.1.2007)

Government to Frame Criteria for Price Negotiations with Pharma MNCs

The government will soon frame a policy to negotiate prices with pharmaceutical corporations by evaluating how much therapeutic benefit new 'cutting edge' drugs offer over similar existing medicines.

The idea is to benchmark the benefits of these premium monopoly drugs against that of a similar; local drug. This will determine the extent of premium the MNCs can charge on the drugs. This, the government thinks, would prevent the abuse of a monopoly position that these companies often enjoy by virtue of either patents or the right to keep the clinical data supporting their drugs to themselves.

The Chemicals Ministry will very shortly set up a committee to decide the benchmarking criteria and categories of medicines that should be subjected to price negotiation. The panel would be constituted of chiefs of drug regulators like the Drugs Controller General of India (DCGI) and the National Pharmaceutical Pricing Authority (NPPA) as members, besides the head of the National Institute of Pharmaceutical Education and Research (NIPER) and ministry officials. It would apply the emerging discipline of pharmaco-economics that health insurance firms abroad use to decide the appropriate cost-effective therapy for reimbursement. The policy would cover all drugs that push their generic copies out of the market with patent protection or with the pioneer company's exclusive use of the drug's clinical data.

The move assumes significance as the government is in the process of finalising a data exclusivity policy for innovator drug companies bent on slowing down the entry of cheaper local copies. The government's plan is to either amend the Drugs and Cosmetics Act administered by the Health Ministry or to fix price ceilings under the Drug Price Control Order administered by the Chemicals Ministry once the parameters are finalised. Price negotiation for monopoly drugs was first suggested by a panel chaired by the Planning Commission's principal advisor Dr Pronab Sen. The panel had said that the government should rely on the price at which other governments purchase drugs in bulk.

(The Economic Times, 29.1.2007)

Pharma Firms Turn to Rural Areas

The Indian pharma market in rural areas - below class VI towns - has witnessed a 39% growth to Rs 5,779 crore in the year ended November 2006, against 18% for the overall domestic pharma market, according to ORG-IMS, a research based consulting firm. This is in stark contrast with previous year's growth. Pharma rural markets had witnessed a 21% growth in the year ended November 2005, and a modest 9% growth in 2004. "Increasing competition and market saturation in metros is leading pharma companies to enter newer markets," said ORG-IMS managing director Shailesh Gadre. Besides, since India's commitment to the WTO's intellectual property regime in January 2005, the window of drugs available with a patent prior to 1995 is becoming smaller. As a result, pharma companies are no longer able to launch new drugs in plenty every year, constraining them to look at new growth strategies in the domestic market.

While new product launches used to contribute to a large share of revenues, they now contribute to only around 1% of the market. "Fifteen per cent of the growth of the market is now coming from volume growth," said Gadre. Expansion of health infrastructure in rural areas has allowed this change. "Increased government spending in roads, telecommunication and health infrastructure has enabled pharma companies to foray into relatively distant pockets of the market, said D G Shah, general, secretary, Indian Pharmaceutical Alliance (IPA).

The states of Assam, West Bengal, Madhya Pradesh and Andhra Pradesh have notably recorded growth in the range of 26-46% in the year ended November 2006. "Many States such as Orissa, Uttar Pradesh or Bihar are however still very far behind, points out Shah. Poor infrastructure remains a major issue in these regions, making it difficult for the industry to foray into these markets.

Pharma sales in Orissa, Bihar and Uttar Pradesh for instance, witnessed a relatively moderate growth at 14%, respectively. "There is still significant scope for growth in India's rural markets. Penetration of the pharma industry in rural India remains considerably lower than that of FMCG companies for instance, said Gadre.

According to ORG-IMS estimates, the domestic pharma market should grow at a CAGR of 13-14% in the next five years. "Abnormalities such as the outbreak of diseases due to flooding, and mosquito-related diseases, have contributed to 2-3% of growth in 2006," explained Gadre. Rural areas should continue to fuel the domestic pharma market's growth, as more players finalise their rural plans.

In rural areas, contagious, infectious and water borne diseases such as diarrhoea, amoebiasis, typhoid, infectious hepatitis, worm infestations, measles, malaria, tuberculosis, whooping cough, respiratory infections, pneumonia and reproductive tract infections continue to dominate the morbidity pattern. However, non-communicable diseases such as cancer, blindness, mental illness, hypertension, diabetes, HIV/AIDS, accidents and injuries are also on the rise.

According to a recent study conducted by the George Institute for International Health in 45 villages in east and west Godavari districts of Andhra Pradesh, diseases of the cardiovascular system, such as heart attacks and stroke caused 32% of deaths in this region.

Death from injury (self-inflicted injury, falls, etc) was the second most common cause (13%). Infectious diseases, such as tuberculosis, intestinal infections and HIV/AIDs caused about 12% of deaths, just ahead of cancer that caused 7% of deaths.

(The Economic Times, 26.1.2007)

Pharma Majors Line up Plans for Retail Business

Pharma firms like Ranbaxy, Zydus Cadila and Himalaya and chains such as Apollo Pharmacies, Medicine Shoppe and Guardian Lifecare are expanding their footprint across the country, while big firms like Reliance are planning to enter the pharma sector with a network of 4,000 pharmacies over the next four years.

The Ranbaxy promoter group is making a foray in pharma retail through a new company, Fortis Health World, which plans to setup 400 stores at an investment of Rs 800 crore over the next five years. The other pharma major, Zydus Cadila has invested in Dial for Health which plans to grow to 210 stores, while herbal healthcare company - Himalaya Drugs - plans to set up 521 stores over the next three years. It is also talking to Reliance Retail to set up stores at their proposed malls and hypermarkets.

Over the next few years chains will also set shop within malls and departmental stores. Some retail chains such as Subiksha are offering discounts on medicines.

Guardian plans to have 3500 stores over the next 8 years. Chains such as CRS Guardian offer alliances with hospitals and pick-up services for pathological tests to draw customers.

(The Times of India, 6.2.2007)

Drug Export to Africa Falls Substantially

Even as the domestic pharmaceutical industry is exploring new markets in Latin America and the Commonwealth of Independent States (CIS), exports to countries in Africa are declining. An important reason for the decline is blacklisting of small and medium-scale pharma companies by authorities in Nigeria and other African countries for alleged supply of unregistered drugs by these companies.

According to a government data, export growth to Nigeria, the seventh largest market for drug exports from India, was 10.7 per cent in 2005-06 compared with a 21.42 per cent growth during 2004-05. In value terms, drug exports to Nigeria grew from $84.47 million in 2003-04 to $102.87 million in 2004-05, and to $113.82 million in 2005-06.

Shipments to countries such as Mozambique, Rwanda and Morocco have also declined. Exports to Morocco grew at 49.59 percent in 2005-06 against 393.75 per cent in 2004-05, to Mozambique at 3.80 per cent against 15.06 per cent in 2004-05 and to Rwanda at 3.2 per cent against 211.85 per cent in 2004-05.

Comet Pharmaceuticals, Coral Laboratories, Kamala Overseas Export, Medico Remedies, Milan Medical Stores and Mission Pharmaceuticals are some of the Indian firms that figure in Nigeria's blacklisted companies. Indian firms continuing to figure in the blacklist have brought bad reputation to the country's drug exporters.

"Nigerian authorities consider all drugs that are not registered in their country as spurious or substandard. The Nigerian drug authorities found some such products of Indian origin and unilaterally decided to blacklist them. The fact, however, is that these products were exported to neighbouring African countries, from where they illegally got entry into Nigeria," P V Appaji, Executive Director, Pharmexcil said.

He added some unscrupulous elements also managed to duplicate Indian brand names thus maligning the genuine drug makers. The Chemical Ministry is also examining the case as it is affecting the reputation of the country's pharmaceutical exporters in general", he said.

(Business Standard, 15.2.2007)

Alembic Buys Dabur’s Non-Oncology Business

Alembic Ltd has decided to acquire the entire domestic non-oncology formulations business of Dabur Pharma for Rs. 150 crore. With this Alembic has entered the high growth lifestyle segment like cardiovascular, diabetic and gastrointestinal drug.

Alembic has a strong presence in the macrolides segment of anti-infective drugs in India, Zero (sugar free), Glycodin (cough syrup) and Althrocin (erythromycin estolae) are some of the company’s leading brands. Dabur Pharma is a significant player in the oncology segment in India.

The move is in line with Dabur Pharma’s strategy to focus on its core oncology business and exit other non-core business. The acquisition will be funded through a combination of internal accrual and debt, according to RK Baheti, director and president Finance, Alembic.

(Financial Express, 2.2.2007)

Sun Pharma Aims for Acquisition in UK

Sun Pharmaceuticals has lined up $500 million to invest for acquisitions in the US, as it bets big on the world's largest drugs market, according to the Sun Pharmaceuticals V-C Investor Relations Uday Baldota. The company, aiming sales of $100 m from the US market this year, had raised about $350 m through convertible bonds and the rest was through internal accruals, he added.

(The Economic Times, 24.1.2007)

Ranbaxy, Cipla Eyes Merck’s Generic Business

Ranbaxy Laboratories has expressed its willingness to bid for the generic business of German pharma company MerckKGaA. "It's a quality asset. We are interested," Ranbaxy chief executive Malvinder Singh said. Ranbaxy's statement came after Merck said that it was evaluating the sale of its patent-freed drugs, which totaled 1.8 billion euros in 2005. A successful acquisition of Merck's generic business would make Ranbaxy the third-largest drug maker after Teva Pharmaceutical Industries of Israel and Sandoz, the generic arm of Switzerland-based Novartis AG.

Meanwhile Cipla is also exploring the option of joining a consortium of private equity firms in bidding for the generics business of Merck KGaA. According to reports, the deal could be valued at $5.2 billion.

Mr Lulla said that Cipla would not invest in the consortium but would contribute by way of expertise to run the company post acquisition.

(The Economic Times, 1.2.2007 and The Financial Express, 15.1.2007)

Ranbaxy Enters Drug Development Deal with GSK

Ranbaxy has struck a new multi year agreement with GlaxoSmithKline to develop molecules in a wide range of therapeutic areas. As part of the arrangement, Ranbaxy receives over $100 million as milestone payments for the product development that GSK plans to launch globally, while the Indian drug company has the domestic rights and royalties.

As per the original agreement signed between the two companies in 2003, Ranbaxy was to conduct the optimization chemistry required to progress drug leads to the stage of candidate selection. The new agreement, however, gives-Ranbaxy the option to take the lead beyond candidate selection to completion of clinical proof of concept. Thereafter, GSK will conduct further clinical development for each programme and take the resulting products through the regulatory approval process to final commercialization.

The products would be launched by GSK in multiple locations across the world on which the Indian drug maker would get double-digit royalties on the net sales. Ranbaxy reserves the right to co-commercialise the products in India, said Malvinder Mohan Singh, chief executive officer and managing directory Ranbaxy Laboratories Ltd.

The new milestones and royalties will apply both to future drug discovery programmes, besides the two ongoing programmes at Ranbaxy, which were agreed upon in the original agreement with GSK, Ranbaxy said in a statement.

(Financial Express, 7.2.2007)

Cadila Exports may Double in 2 Years

Cadila Pharmaceuticals is planning to nearly double exports over the next two years from export revenues of Rs 200 crore in calendar year 2006.

Cadila's formulation exports have risen nearly 10-fold from Rs 20 crore in 2002 to Rs 115 crore in 2006. According to CPL president (international business) P K Guha, last year around Rs 45-crore export sales were made in Africa, Rs 20 crore went to Russia and the CIS countries and SE Asia accounted for another Rs 18 crore. "If some of our registrations in different countries get cleared this year, then formulation exports may grow 40-50% against the targeted 30%," says Guha. The company rules set an ambitious target of Rs 500 crore worth of sales from active pharmaceutical ingredients (APIs) by 2010 from about Rs 100 crore in 2006. "Out of the projected Rs 500 crore API sales, 90-95% will be from exports," says CPL vice-president (API marketing) S Narayanan. "We will submit our first four ANDAs in the US this year to tap the world's largest generics market. Cadila has set up a new joint venture company Modawar with an US partner for its generics business there," says Cadila Pharmaceutical Chairman I.A. Modi. In 2006, Cadila filed 10 DMFs in the US and this year 15-16 more will be filed for marketing API drugs.

(The Economic Times, 23.1.2007)

Pharma Cos Eye Global Cancer Drugs Market

The Indian pharma industry is gearing up to introduce oncology drugs in the international market. Treatment for cancer is estimated to become the largest sales value area at $55 billion by 2009, from the current $45 billion. The cancer accounts an estimated 7.6 million deaths globally.

The oncology pipeline is the richest in number and potential value, with a high number of pharmaceutical and biotech companies focusing on oncology drugs. Over 50 new oncology products will be launched in the next five years with new players entering the market. About 30% of all launches by 2010 will be in oncology.

'The global oncology drug market is growing at 17% annually and the current size of the Indian cancer drug market is Rs 800 crore and this is expected to treble by 2010," it has been learnt.

Pharmaceuticals and biotech companies like Biocon, Ranbaxy, Dr Reddy's, Sun Pharma, Nicholas Piramal, Dabur and AstraZeneca are already here with a slew of drugs.

Biocon recently launched its monoclonal antibody-based drug BIOMAb-EGFR for treating solid tumors. The company is looking at introducing products in the twin markets of the US and Europe.

Dabur Pharma recently introduced a nano technology-based chemotherapy agent, Nanoxel, in the country and plans to take it to the US and the European markets and have already planned clinical trials there.

Ranbaxy Laboratories Ltd has entered into a strategic alliance with Zenotech Laboratories Ltd where Ranbaxy will market the latter's products in the global market.

(The Financial Express, 5.2.2007)

Glenmark to Enter Europe with Rs 100 Cr Acquisition

Glenmark Pharmaceuticals would soon enter the European market by acquiring a front-end pharmaceutical company for about Rs 100 crore. Glenmark MD Glenn Saldanha has disclosed that the target company is in Central Europe and the deal is likely to be through very shortly. It has a strong marketing force and some approved products, Mr Saldanha said without disclosing the company's name.

The company is also in talks with a few MNCs to licence out the Europe rights for its experimental asthma drug oglemilast. US-based Forest Laboratories Inc has the North American market rights and Teijin Pharma has the Japanese market rights for the drug. It is now undergoing phase-II clinical trials in the US. Glenmark will retain the rights for the rest of the markets.

Glenmark has another three experimental drugs for obesity, rheumatoid arthritis and pain management at preclinical stage, which are set to enter clinics later this year. The company intends to license all of them out to MNC partners by the end of next year.

(The Economic Times, 12.2.2007)

Actavis Buys Sanmar's API Manufacturing Unit

Actavis, an Iceland based generic drug manufacturer in the world, has acquired the API (Active Pharmaceutical Ingredient) manufacturing division of Sanmar Speciality Chemicals (SSCL), a subsidiary of the Chennai-based Sanmar Group. The acquisition price is not disclosed.

SSCL’s API division offers Actavis a wholly-owned FDA approved facility and the ability to develop and manufacture its own APIs, the single largest cost component in the group's manufacturing. The company had done two acquisitions in India earlier, the Chennai based Grandix Pharmaceuticals in December 2006 and Lotus Laboratories, a Bangalore-based CRO (Contract Research Organisation), acquired in February 2005.

SSCL’s FDA approved facility, located at Alathur near Chennai supplies APIs to international pharmaceuticals companies, mostly in Europe and the US. The plant is capable of undertaking complex reactions and the division currently manufactures 15 products and employs approximately 70 people. A company press release said as part of this acquisition, Actavis has also entered into a service agreement with SSCL to provide Actavis with API research and development services at SSCL’s research facilities.

Actavis now has over 620 people employed in India, with operations in Chennai, Bangalore and Hyderabad. The Actavis group has 10,000 employees operating in 30 countries around the globe.

(Business Standard, 14.2.2007)

Glaxo Delegation in India for Brand, Tech Acquisitions

GlaxoSmithKline (GSK) international team has visited country to explore possibilities of acquiring brands in health and wellness space. The company is looking at segments like nutrition products, OTC drugs, and technologies, which could help support its growth in high-potential areas. The company currently enjoys about 70% share in the health, drinks segment in India. The company also plans to introduce some of its international brands like Lucozade (health-drink), Sensodyne (toothpaste) and over the counter (OTC) drugs.

It currently sells brands such as Horlicks, Maltova, Viva and Boost and OTC brands like Crocin, Eno and Iodex. The team headed by its senior vice-president (worldwide business development and strategic alliances) Catherine Angell Sohn, has flown in from Philadelphia and plans to talk to key players in the industry, including merchant bankers to fuel its inorganic growth in the segment which is yet unexplored.

“We are in early stages of exploring investments in India but our focus is sharp as we want to acquire companies with presence in healthcare and wellness. The company expects to identify brands of interest over the next 12-18 months," Sohn said. The company is also looking at technologies which could help develop innovative products to strengthen its portfolio in the same domain.

(Financial Express, 8.2.2007)

Alembic Targets Lifestyle Drug Firm

Alembic is keen to acquire the formulations business of a domestic pharma company with a strong presence in .segments like lifestyle disease and dermatology. Alembic's CMD Chirayu Amin said the company is eyeing an acquisition that will entail investment of approximately Rs 50-100 crore.

"The acquisition is being planned to beef up our existing product portfolio in lifestyle drug segment and enter into new categories like dermatology. It will be funded through a combination of internal accruals and debt," said Mr Amin.

The acquisition plan of the company is in line with its strategy to improve its domestic market share in the high growth therapeutic segments like diabetes, cardio-vascular, gynaecology and gastro-intestinal. With such an aim, it announced the acquisition of Dabur Pharma's non-oncology formulation business for Rs 159 crore.

By virtue of its acquisitions strategy, Alembic is targeting a 30% top line growth in 2007-08 from Rs 700 crore now. It also sees contract research and manufacturing (CRAM) deals with foreign pharma companies as prime growth drivers. The company has already signed CRAM deals with 10 pharma companies in the US and Europe.

(The Economic Times, 8.2.2007)

Ranbaxy Attains Rs. 520 Crore Profit in 2006

Ranbaxy Laboratories has recorded a strong performance in the year ended December 31, 2006, with domestic sales at Rs. 1,158 crore, a rise of 19 per cent. For the fourth quarter ended December 2006, sales stood at Rs. 273.20 crore and the net profit has reported Rs. 185.90 crore (Rs. 69.60 crore), according to a company release.

Restructuring of domestic operations in line with customer groups and investment in high growth segments supported by new products sourced from in-house development, supply partners and in-licensing opportunities fuelled the growth in 2006.

For the year 2006, the company recorded consolidated global sales of Rs. 6,069.80 crore ($1340 million) against Rs. 5.188 crore ($1,176 million), registering a growth of 17 per cent. The profit after tax was Rs. 520.40 crore ($115 million) against Rs. 264.20 crore ($60 million). The company had robust sales across markets of US, BRICK, Africa, Latin America, Middle East and the Asia Pacific.

In the fourth quarter, the company has entered into an exclusive licensing agreement with the Debiopharm Group, a Swiss biopharmaceutical development company, to market its New Chemical Entity (NCE), Sanvar (vapreotide acetate) in India, Bangladesh and Nepal. The company’s global consumer healthcare business recorded sales of $19 million for the year, a growth of 15 per cent over the previous year. In the fourth quarter, sales stood at $5 million, a rise of 8 per cent.

The company in the quarter under review entered into a share purchase agreement on December 1, 2006 to acquire Be-Tabs, South Africa, for a total consideration of about $70 million.

(The Hindu, 19.1.2007)

Maneesh Pharmaceuticals Acquires Brazilian Firm

Maneesh Pharmaceuticals acquired laboratorio Sanobiol Ltda, the third largest manufacturer of IV Fluids hospital products in Brazil in a deal worth $8 million. Sanobiol has an ANVISA approved facility and caters to the large market share in the hospital segments in Brazil, and is the third largest manufacturer for such parenterals as intravenous fluids, intravenous access devices and infusion equipment in Brazil.

(The Financial Express, 16.1.2007)

Regulatory

Bulk Drugs Price Fixation

In exercise of the powers, conferred by the Drugs (Prices Control) Order, 1995 read with the Ministry of Chemicals and Fertilizers number S.O. 637 (E), dated the September 4, 1997, the National Pharmaceutical Pricing Authority hereby fixes the prices given below as the maximum sale price (exclusive of excise duty and local taxes) at which the bulk drug specified below shall be sold.

TABLE

Notification No. & Date	Name of the bulk drug	Unit	Maximum Sale Price (Rs.) (Exclusive of excise duty and local taxes)
(1)	(2)	(3)	(4)
2129(E) 20.12.2006	Betamethasone Alcohol	Gm.	188.00
2129(E) 20.12.2006	Betamethasone Valerate	Gm.	178.00
2129(E) 20.12.2006	Betamethasone Di-sodium Phosphate	Gm.	152.00
2130(E) 20.12.2006	Ranitidine Hydrochloride	Kg.	643.00

Ceiling Price Fixation

In exercise of the powers, conferred by the Drugs (Prices Control) Order, 1995 read with the Ministry of Chemicals and Fertilizers number S.O. 637 (E), dated the September 4, 1997, issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority hereby fixes the prices as the ceiling price exclusive of excise duty and local taxes, if any for scheduled formulations specified below with the strength and pack size specified respectively in the corresponding entries.

Notification Date: 14.02.2007

Notification No	Name of the Formulation	Strength	Pack Size	Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)
Each tablet contains
199(E)	Analgin Tablets	Analgin -500 mg	10's Strip/Blister	5.12
199(E)	Analgin Tablets	Analgin -500 mg	2ml Ampoule	3.72
Each ml of infusion contains
200(E)	Multivitamin Infusion (with Amino Acid)	Vitamin A (as Palmitate) - 1000IU Cholecalciferol - 100IU Riboflavine Phosphate - 1.4mg Thiamine HCl - 5mg Pyridoxine HCl - 1.5mg D-Panthenol - 2.5mg Nicotinamide - 10mg, Ascorbic Acid - 50mg Alpha Tocopheryl Acetate - 0.5mg L-Arginine HCl - 6.5mg L-Histidine HCl Mono - 3mg L-Isoleucine - 5.5mg , L-leucine - 12.3mg L-Lysine HCl - 17.0mg, L-Methionine - 6mg L-Phenylalanine - 8.7mg, L-Threonine - 5.4mg L-Valine - 6.1mg, Glycine - 10mg	10ml Ampoule	8.62
200(E)	Multivitamin Infusion (with Amino Acid)	Vitamin A (as Palmitate) - 1000IU Cholecalciferol - 100IU Riboflavine Phosphate - 1.4mg Thiamine HCl - 5mg Pyridoxine HCl - 1.5mg D-Panthenol - 2.5mg Nicotinamide - 10mg, Ascorbic Acid - 50mg Alpha Tocopheryl Acetate - 0.5mg L-Arginine HCl - 6.5mg L-Histidine HCl Mono - 3mg L-Isoleucine - 5.5mg , L-leucine - 12.3mg L-Lysine HCl - 17.0mg, L-Methionine - 6mg L-Phenylalanine - 8.7mg, L-Threonine - 5.4mg L-Valine - 6.1mg, Glycine - 10mg	10ml Ampoule with Hologram	8.70
Each 5ml contains
201(E)	Ibuprofen Suspension	Ibuprofen -100mg	60ml Bottle with M. Cup	11.72
Each capsule contains
202(E)	Vitamin E + Vitamin C + Glucosamine Sulphate Sodium Capsules	Vitamin E Acetate - 25mg (as Vitamin E Acetate Dry Powder 50%) Vitamin C (coated) -50mg Glucosamine Sulphate Sodium-750mg	10's Strip/Blister	18.02
Each 5ml contains
203(E)	Pseudoephedrine + Chlorpheniramine Maleate+ Paracetamol Syrup	Pseudoephedrine -15mg Chlorpheniramine Maleate-1mg Paracetamol -125mg	60ml Bottle with M. Cup	12.32
Each ml contains
204(E)	Pheniramine Maleate Injections	Pheniramine Maleate -22.75mg	10ml Vial	7.68
204(E)	Pheniramine Maleate Injections	Pheniramine Maleate -22.75mg	10ml Vial with Carton	8.58
Each film coated tablets contains
205(E)	Ranitidine Tablets	Ranitidine Hydrochloride eq. to Ranitidine 150 mg	10's Al_St	4.52
205(E0	Ranitidine Tablets	Ranitidine Hydrochloride eq. to Ranitidine 300 mg	10's Al_St	7.78
205(E)	Ranitidine+Domperidone Tablets	Ranitidine Hydrochloride eq. to Ranitidine 150 mg Domperidone - 10 mg	10's Al_St	5.20
Each 2ml ampoule contains
205(E)	Ranitidine Injections	Ranitidine -50mg (as Ranitidine HCL)	5x2ml Ampoule	14.96
Each film coated tablets contains
206(E)	Metronidazole Tablets	Metronidazole - 200mg	10's Strip/Blister	3.62
206(E)	Metronidazole Tablets	Metronidazole - 400mg	10's Strip/Blister	5.94
Each coated tablets contains
206(E)	Metronidazole + Diloxanide Furoate Tablets	Metronidazole - 400mg Diloxanide Furoate -500mg	15's Strip/Blister	19.88
Each 5ml contains
206(E)	Metronidazole Suspension	Metronidazole Benzoate eq. to Metronidazole - 200mg	30ml Bottle with M. Cup	8.46
206(E)	Metronidazole Suspension	Metronidazole Benzoate eq. to Metronidazole - 200mg	60ml Bottle with M. Cup	12.74
Each 5ml contains
207(E)	Ibuprofen Suspension	Ibuprofen -100mg	100ml Bottle with M. Cup	15.06
207(E)	Ibuprofen+Paracetamol Suspension	Ibuprofen -100mg Paracetamol -162.5mg	60ml Pet Bottle with M. Cup	13.70
207(E)	Ibuprofen+Paracetamol Suspension	Ibuprofen -100mg Paracetamol -162.5mg	60ml Pet Bottle with M. Cup & Carton	14.90
Each 5ml contains
208(E0	Ibuprofen+Paracetamol Suspension	Ibuprofen -100mg Paracetamol -162.5mg	60ml Glass Bottle with M. Cup	11.08
Each ml contains
209(E)	Vitamin A Injection	Vitamin A (as palmitate)- 40000IU	2.5ml Amber Ampoule	4.18
Each tablet contains
210(E)	Griseofulvin Tablets	Griseofulvin -125mg	10's Strip/Blister	6.72
210(E)	Griseofulvin Tablets	Griseofulvin -250mg	10's Al_St	12.56
210(E)	Griseofulvin Tablets	Griseofulvin -250mg	10's Al_Bl	12.32
210(E)	Griseofulvin Tablets	Griseofulvin -375mg	10's Al_St	18.40
210(E)	Griseofulvin Tablets	Griseofulvin -375mg	10's Al_Bl	18.08
210(E)	Griseofulvin Tablets	Griseofulvin -500mg	10's Al_St	24.22
210(E)	Griseofulvin Tablets	Griseofulvin -500mg	10's Al_Bl	23.80
Each 3ml contains
211(E)	Salbutamol Solutions	Salbutamol Sulphate eq. to Salbutamol-2.5mg	3ml Soln. Ampoule	3.19
Each 5ml contains
211(E)	Salbutamol Expectorent / Syrup	Salbutamol - 2mg	56ml Bottle	4.83
211(E)	Salbutamol + Bromhexine HCl Expectorent / Syrup	Salbutamol - 1mg Bromhexine Hcl - 4mg	100ml Bottle	11.72
211(E)	Salbutamol + Guaiphensin Expectorent / Syrup	Salbutamol - 2mg Guaiphensin 100mg	110ml Bottle	6.47
Each CR/SR/DR/TR tablet contains
211(E)	Salbutamol +Theophylline Tablets	Salbutamol Sulphate - 4 mg Theophylline (anhydrous)- 200 mg	10's Strip/Blister	4.46
Each CR/SR/DR/TR capsule contains
211(E)	Salbutamol +Theophylline Capsule	Salbutamol Sulphate - 4 mg Theophylline (anhydrous)- 200 mg	10's Strip/Blister	6.58
Each capsule /capsule for inhalation contains
211(E)	Salbutamol + Beclomethasone Capsule	Salbutamol 200mcg Beclomethasone 100mcg	20's Strip/Blister	10.88
Each capsule contains
212(E)	Cloxacillin + Ampicillin+ Lactic Acid Bacillus Capsules	Cloxacillin Sodium eq. to Cloxacillin - 250 mg Ampicillin Anhydrous - 250 mg Lactic Acid Bacillus spores - 20 Millions	10's Strip/Blister	17.62
212(E)	Cloxacillin+Ampicillin+ Lactic Acid Bacillus Capsules	Cloxacillin Sodium eq. to Cloxacillin - 250 mg Ampicillin Anhydrous - 250 mg Lactic Acid Bacillus spores - 60 Millions	10's Strip/Blister	17.68
212(E)	Cloxacillin+Ampicillin+ Lactic Acid Bacillus Capsules	Cloxacillin Sodium eq. to Cloxacillin - 250 mg Ampicillin (as Trihydrate)- 250 mg Lactic Acid Bacillus spores - 90 Millions	10's Strip/Blister	17.32
Each film coated tablet contains
212(E)	Cloxacillin + Ampicillin Tablets	Cloxacillin Sodium eq. to Cloxacillin - 500 mg Ampicillin (as Trihydrate)- 500 mg	10's Strip/Blister	28.66
Each vial contains
212(E)	Cloxacillin + Amoxycillin Injections	Cloxacillin 1gm Amoxycillin 1gm	1 Vial	25.90
212(E)	Cloxacillin + Amoxycillin Injections	Cloxacillin 25mg Amoxycillin 50mg	1 Vial	6.04
Each tablet contains
213(E)	Chlorpromazine + Trifluoperazine + Trihexylphenidyl Tablets	Chlorpromazine Hcl. - 25 mg Trifluoperazine Hcl. - 5 mg Trihexylphenidyl Hcl - 2 mg	10's Strip/Blister	2.86
213(E)	Chlorpromazine + Trifluoperazine + Trihexylphenidyl Tablets	Chlorpromazine Hcl. - 50 mg Trifluoperazine Hcl. - 5 mg Trihexylphenidyl Hcl - 2 mg	10's Strip/Blister	3.66
213(E)	Chlorpromazine + Trifluoperazine + Trihexylphenidyl Tablets	Chlorpromazine Hcl. - 100 mg Trifluoperazine Hcl. - 5 mg Trihexylphenidyl Hcl - 2 mg	10's Strip/Blister	5.28
Each 2ml contains
214(E)	Dexamethasone Injections	Dexamethasone (as Sodium Phosphate)-4 mg	2ml Ampoule	3.32
Each 10ml contains
214(E)	Dexamethasone + Ofloxacin Eye/Ear Drops	Dexamethasone - 0.1 %w/v Ofloxacin - 0.3% w/v	10ml Vial with Dropper & Carton	10.14
Each 5ml contains
214(E)	Dexamethasone + Neomycin+ Boric Acid Eye Drops	Dexamethasone Sodium Phosphate - 0.11 % w/v Neomycin Sulphate - 0.5 % w/v Boric Acid - 1.2 % w/v	5ml Vial with Dropper & Carton	7.92
Each ml contains
214(E)	Dexamethasone + Ciprofloxacin Eye/Ear Drops	Dexamethasone 0.1%w/v Ciprofloxacin 0.3% w/v	10ml Vial with Dropper & Carton	9.34
Each gm contains
215(E)	Betamethasone Cream	Betamethasone Valerate 0.1% w/w	50gm Tube	14.50
Each 5ml contains
216(E)	Metronidazole + DiloxanideFuroate Suspension	Metronidazole 100mg Diloxanide Furoate 125mg	112ml Bottle with M. Cup	15.28
216(E)	Metronidazole + DiloxanideFuroate Suspension	Metronidazole 100mg Diloxanide Furoate 125mg	50ml Bottle with M. Cup	8.25
Each tablet contains
217(E)	Dexamethasone Tablet	Dexamethasone Sodium Phsophate eq. to Dexamethasone-0.5mg	10's Strip/Blister	1.76
217(E)	Dexamethasone Tablet	Dexamethasone Sodium Phsophate eq. to Dexamethasone-0.5mg	10 x 10's Strip/Blister	15.34
217(E)	Dexamethasone Tablet	Dexamethasone Sodium Phsophate eq. to Dexamethasone-0.5mg	2000's Jar	181.56
217(E)	Dexamethasone Tablet	Dexamethasone Sodium Phsophate eq. to Dexamethasone-0.5mg	1000's Jar	94.42
217(E)	Dexamethasone Tablet	Dexamethasone Sodium Phsophate eq. to Dexamethasone-0.5mg	500's Jar	50.10
217(E)	Dexamethasone Tablet	Dexamethasone Sodium Phsophate eq. to Dexamethasone-1.0mg	10's Strip/Blister	1.92
217(E)	Dexamethasone Injection	Dexamethasone-4.0mg (as Sodium Phsophate)/ml	2ml Vial	6.48
217(E)	Dexamethasone Injection	Dexamethasone Sodium Phsophate eq. to Dexamethasone-20mg /ml	5ml Vial	18.16
217(E)	Dexamethasone + Gentamycin Eye/Ear Drops	Dexamethasone -0.1% w/v (as Dexamethasone Sod. Phosphate) Gentamycin-0.3%w/v (as Gentamycin Sulphate)	5ml Vial Dropper with Carton	8.06
Each ml contains
217(E)	Dexamethasone + Tobramycin Eye/Ear Drops	Dexamethasone -1mg Tobramycin - 3mg	5ml Bottle with Dropper & Carton	9.62
217(E)	Dexamethasone + Tobramycin Eye/Ear Drops	Dexamethasone Sodium Phosphate-0.1% w/v Tobramycin Sulphate eq. to Tobramycin-0.3%w/v	5ml Glass Vial with Dropper & Carton	9.62
217(E)	Dexamethasone + Gentamycin Drops	Dexamethasone-0.1% w/v Phosphate-0.1%w/v Gentamycin Sulphate - 0.3% w/v	10ml Vial with Dropper	10.16
217(E)	Dexamethasone Drop	Dexamethasone Sodium Phosphate-0.01% w/v	10ml Bottle with Dropper & Carton	6.40
217(E)	Dexamethasone + Neomycin Drop	Dexamethasone Sodium Phosphate-0.1% w/v Neomycin Sulphate -0.5% w/v	10ml Bottle with Dropper	9.72
217(E)	Dexamethasone Injection	Dexamethasone -4mg / ml	10ml Vial	11.24
217(E)	Dexamethasone Injection	Dexamethasone -4mg / ml	20ml Vial	17.32
217(E)	Dexamethasone + Framycetin+ Clotrimazole Cream	Dexamethasone Acetate-0.1% w/w Framycetin Sulphate-1% w/w Clotrimazole-1%w/w	15gm Tube	17.44
Each gm contains
217(E)	Dexamethasone+ Neomycin Sulphate+ Polymixin B Sulphate Ointment	Dexamethasone -1mg Neomycin Sulphate - 3.5 mg Polymixin B Sulphate-5000units	3gm Tube	5.78
217(E)	Dexamethasone + Chloramphenicol Ointment	Dexamethasone Sod. Phosphate-1mg Chloramphenicol-10mg	5gm Tube	5.16
Each ml contains
218(E)	Multivitamin Drops	Vitamin A 750 IU (as Vitamin A Concentrate - Oily form ) Cholecalciferol - 200 IU Riboflavin - 0.5 mg Thiamine Hydrochloride - 0.5 mg Pyridoxine Hydrochloride - 0.5 mg Zinc sulphate - 11.0 mg (Eq. to 2.5 mg of elemental Zinc) Nicotinamide - 5.0 mg Inositol - 7.5 mg Choline Chloride - 3.46 mg	30ml Bottle with Dropper & Carton	8.16
Each tablet contains
219(E)	Frusemide + Triamiterene Tablets	Frusemide 20 mg Triamiterene - 50 mg	10's Strip/Blister	3.12
219(E)	Frusemide + Triamiterene Tablets	Frusemide 40 mg Triamiterene - 50 mg	10's Strip/Blister	3.34
Each tablet contains
220(E)	Trimethoprim Tablets	Trimethoprim 100mg	10's Strip/Blister	2.07
Each gm contains
221(E)	Beclomethasone Dipropionate + Chinofrom (ICHQ) Cream	Beclomethasone Dipropionate - 0.025% w/v Chinofrom (ICHQ) 3% w/w	5gm Tube	2.59
Each capsule contains
222(E)	Doxycycline Hyclate + Lactic Acid Bacillus Capsules	Doxycycline Hyclate eq. to Doxycycline 100mg Lactic Acid Bacillus 30 million spores	10's Strip/Blister	4.30
Each tablet contains
223(E)	Pyrantel Pamoate + Mebendazole Tablets	Pyrantel Pamoate-100mg base Mebendazole 150mg	2's Strip/Blister	2.58
Each tablet contains
224(E)	Pseudoephedrine + Cetrizine Tablets	Pseudoephedrine HCl. - 30 mg Cetrizine Di Hydrochloride - 10 mg	10's Strip/Blister	2.94
224(E)	Pseudoephedrine + Cetrizine Tablets	Pseudoephedrine HCl. - 60 mg Cetrizine - 5 mg	10's Strip/Blister	3.80
Each 5ml contains
224(E)	Pseudoephedrine + Bromohexine + Chlorpheniramine Maleate Expectorant	Pseudoephedrine HCl - 80mg Bromohexine HCl - 4mg Chlorpheniramine Maleate - 2mg	100ml Bottle	17.80
224(E)	Pseudoephedrine + Paracetamol + Chlorpheniramine Maleate Syrup	Pseudoephedrine Hcl -30 mg Paracetamol - 125 mg Chlorpheniramine Maleate - 1mg	60ml Bottle with M. Cup	11.08
Each tablet contains
225(E)	Naproxin Sodium Tablets	Naproxin Sodium 275 mg	10's Strip/Blister	13.00

Draft Pharma Policy Referred to Group of Ministers

The Union Cabinet has forwarded the draft pharmaceutical policy to a Group of Ministers (GoM) for further consideration. The policy, which along with other measures seeks to bring essential medicines under price control, has been strongly opposed by the industry. "A GoM will be appointed to look into the entire aspect and it will come back to the Cabinet shortly. The policy is expected to come up in the next Parliamentary session - the Budget session," informed Mr. P.R. Dasmunsi, Minister of Information and Broadcasting and Parliamentary Affairs.

The Cabinet has approved of the setting up of a Central Drugs Authority of India as an autonomous organisation under the Ministry of Health and Family Welfare to be located at the Food and Drug Bhawan, New Delhi. It has also approved centralising the licensing of drug manufacturing units from the States to the Union Government. The transition is to occur in a phased manner over five years.

According to Mr Paswan, the draft pharma policy that seeks to implement a Supreme Court directive of 2003 to make essential medicines affordable has been true to its purpose. "The Supreme Court order very specifically says the two words 'Price' and 'Control' and there is no question of having misinterpreted that," he said. The Minster also said that it had returned the powers withdrawn by the previous government to the National Pharmaceutical Price Authority to bring under price control "any" drug in public interest. This provision is provided under the para 10(B) of the DPCO, said Mr. Paswan.

The industry has always strongly opposed price control of medicines on a cost base and suggested that only an unreasonable hike in prices of essential medicines be checked.

(Chemical Weekly, 23.1.2007)

NPPA to Check Exhorbitant Drug Price Rise

Government has delegated powers to National Pharmaceutical Pricing Authority (NPPA) under which it can autonomously revise the prices of drugs downwards, allowing an annual increase of 20%, in case of an "unjustified" price rise.

Recently, the government restored powers to NPPA under which it can control and fix prices of decontrolled drugs under Section 10 (b) of the Drug Price Control Order 1995, in case of any "aberration or exhorbitant increase in medicine prices". The draft pharma policy, which has been referred to a group of ministers, proposes to bring the threshold limit down to 10% in a year.

Till 1999, the drug regulator had powers under Section 10 (b) of the Drug Price Control Order to control and revise prices of decontrolled drugs, outside the purview of price control. The notification issued by government recently enables NPPA to check drug prices in cases of extreme fluctuations or anything that may be in the general interest of the public and consumers.

It will not only help the NPPA to act faster against companies but also avoid duplication of efforts between the government and authority, the official added. Under the earlier system, the NPPA referred cases to the government where the price increase in the particular drug was over 20% in a year.

(Times of India, 10.2.2007)

OPPI Demands Excise Duty Cut on Drugs

The Organization of Pharmaceutical Producers of India (OPPI) has demanded a cut in excise duty on drugs to 8 per cent from the present 16 per cent in the forthcoming budget.

Another demand of the industry was of zero excise duty on life-saving drugs, said Ranjit Shahani, OPPI president who is also the Vice-Chairman and Managing Director of Novartis India. He said the proposals by Chemicals and Fertilisers Minister Ram Vilas Paswan in the new pharma policy were not conducive to the growth of the industry.

The proposed policy had suggested price control on 223 out of the 354 drugs in the National List of Essential Medicines (NLEM) under the cost based mechanism. The pharmaceutical industry strongly objected to it, calling it a retrograde step and eventually the Cabinet referred it to a Group of Ministers to be constituted by the Prime Minister to look into the matter.

Indian pharmaceutical industry had suggested that there should be a price monitoring mechanism instead of direct control. Industry body FICCI had written to the Prime Minister against the move by the Chemicals and Fertilisers Minister. CII also criticised the proposed policy as one that would not only hurt the industry but also the consumers.

(Business Standard, 17.1.2007)

Ministry Proposes Tax Refund on Emergency Aid by Pharma Firms

The Chemicals and Fertilisers Ministry has recommended that the companies should be refunded the amount of customs duty, value-added tax (VAT) and the central excise duty that has been paid on the medicines distributed during a national health emergency. During a crises, companies often distribute medicines from the duty-paid goods cleared for the market, that are lying with their distributors and not from the factory. The idea is to refund the money paid to the government that companies do not recoup from the consumer, in times of emergency. Some medicines attract a 12.5% peak customs duty while a large number of life-saving drugs attract a 5% concessional duty and some others are exempted. The companies also pay 4% VAT in all states except Uttar Pradesh, and a 16% excise duty on 60% 0f the maximum retail price.

The proposal is part of the ministry's pre-budget recommendations. Other demands include total Customs and excise duty exemptions on all cancer and Aids drugs irrespective of whether they are part of the national essential drug list and reduction in the 16% excise duty on all drugs by half.

(The Economic Times, 12.1.2007)

Drug Companies to Stop Freebies to Doctors

Pharmaceutical companies have decided to apply a code on themselves, restricting travel, gifts, shopping and entertainment expenses offered to doctors for promotion of medicines.

The code, drawn up by Organisation of Pharmaceutical Producers of India which represents companies that control nearly two-thirds of the medicine market, comes into effect from this month. The organisation said the curbs are in line with international standards and support self-regulation through compliance.

The code also seeks to restrain companies from making tall claims while promoting medicines. It says that promotion of medicines should encourage the appropriate use by presenting them objectively and without exaggerating their properties.

(The Times of India, 17.1.2007)

Pawar to Head GoM on Drug Prices Control

The government has referred the group of ministers (GoM) to resolve the long pending issue of bringing more drugs under the ambit of cost based price control. Agriculture and Consumer Affairs Minister Sharad Pawar would head the group that includes Commerce and Industry Minister Kamal Nath, Health Minister Anbumani Ramadoss, Science and Technology Minister Kapil Sibal, Law Minister H R Bhardwaj, and Deputy Chairman of Planning Commission Montek Singh Ahluwalia, besides Chemicals and Fertilisers Minister Ramvilas Paswan;

The Union Cabinet, in its meeting on January 11, 2007, considering a sharp divide between the pharma industry and the chemicals department on cost based price control, had referred the matter to GoM, even as the industry had proposed a price monitoring mechanism instead of direct control.

The domestic industry has strongly opposed the increase in the ambit of price control from current 74 bulk drugs to another 260 formulations, saying it would bring 60% drugs under direct control, while the chemicals department said it would cover another 12% drugs over the current 20%.

(The Financial Express, 3.2.2007)

Pharma Industry Finds New Pharma Policy Discouraging

The Chemicals and Fertilisers Minister Ram Vilas Paswan's efforts to introduce enhanced price controls for pharma products, by bringing in a new drug policy, came under direct attack by the industry. Companies like Ranbaxy, Nicholas Piramal and Biocon said the government's policy on price control was not in the interest of the industry and consumers.

Separately the newly elected president of Federation of Indian Chambers of Commerce and Industry (FICCI) Habil Khorakiwala, who's also the chairman of pharma company Wockhardt Ltd, wrote to the Prime Minister urging that the proposed policy will increase the range of price controlled drugs from the current 74 to 260 covering practically 60% of the industry. He said that the policy would be going back to the licence era and lead to the industry curtailing production of drugs because of unremunerative prices.

''The drug policy being pursued by the government is not in the interest of the customer or the industry," Malvinder Singh, CEO of Ranbaxy, who is also the chairman of CII's national committee on technology and IPR said.

Singh said that the drug prices in the country were the lowest in the world (even among developing countries) and the presence of 20,000 pharmaceutical manufacturers in India created an adequate pricing control mechanism. Pharma prices had gone down year-on-year for the past few years, he added.

Citing India as a possible global hub for pharmaceuticals Singh said, "We need a powerful and successful pharma industry". Stressing the need to quadruple investment in R&D, Singh said that pharma companies needed to be viable and able to invest in R&D themselves. Price control ideally should be removed altogether but if that is not possible then the government should maintain a status quo with the current regulations.

''The data presented to the Satwant Reddy committee by industry does not seem to have made an impact on the government. The final draft has not captured the industry's views," Swati Piramal, director, strategic alliances and communications at Nicholas Piramal said. The minister should be worried as only the Indian pharma companies are doing research in diseases that affect India, she added.

Medicines contribute only 15% of healthcare spend for average patient and the Indian pharma industry is now the highest spender on R&D with Rs 2,375 crore last year. This is double the amount spent on R&D in the auto sector and far higher than what is spent on the IT sector.

(The Financial Express, 11.1.2007)

GE Acquires Abbott’s Diagnostics Units for $8.13b

General Electric has decided to buy two of Abbott Laboratories Inc's diagnostics business units for $8.13 billion in cash. GE said it would buy Abbott's primary in vitro diagnostics, which involve routine laboratory tests, and its point-of-care diagnostics business - tests done typically at a patient's bedside such as blood chemistry work.

Abbott's more-profitable molecular diagnostics business, including sophisticated tests for bladder cancer and susceptibility to breast cancer, and its lucrative diabetes-care businesses are not part of the transaction. Abbott's retention of its diabetes and molecular diagnostics portfolio - will aid the company's strategy of steadily boosting its overall profit margins, Weinstein said.

Healthcare is one of GE's faster-growing businesses and an area of focus. The company's healthcare unit accounted for 14.2% of GE profits and 9.9% of revenue through the first nine months of 2006.

(The Economic Times, 20.1.2007)

Novo Nordisk Cuts Jobs, Stops Non Biotech Research

Novo Nordisk A/S, the world's largest insulin maker, will cut as many as 180 jobs as the company stops research into non-biotechnology treatments. Research and development will focus on exclusively on protein-based drugs, Bagsvaerd, Denmark-based Novo Nordisk said in a statement to the Copenhagen stock exchange. Current projects in so-called small molecules will be disposed, the company said. About half of the affected workers may be offered new positions with the company. Novo Nordisk concentrates on treatments for diabetes, blood clotting and growth disorders, for which the company has developed protein based drugs including Levemir and NovoSeven.

(Business Standard, 16.1.2007)

Pfizer Unveils Big Revamping Plan

Pfizer has drawn an extensive restructuring plan includes the elimination of 10000 jobs and the closure of manufacturing and research facilities around the world. The moves target annual after- tax cost savings of $l.5 billion to $2 billion by the end of 2008. Pfizer CEO Jeffrey B Kindler has outlined a plan to create business units that are smaller and more entrepreneurial. Three or four layers of management will be cut in many divisions, he said.

Research teams that now are scattered around the globe will focus on specific therapeutic areas at one of four major research centers. At the same time, Kindler said, the company will step up its program to obtain outside drug candidates, claiming that Pfizer plans to launch two new externally sourced products each year beginning in 2010.

The job cuts, which include the elimination of 2,200 U.S. sales positions announced last month represent a 10% reduction in Pfizer's worldwide workforce. Pfizer will close manufacturing sites in Brooklyn, N.Y., and Omaha, Neb., and is in labor negotiations over the proposed sale of its Feucht, Germany site. The company plans to close three U.S. research sites, all in Michigan-two in Ann Arbor and one in Kalamazoo, where it will maintain manufacturing for its animal health business. Pfizer is negotiating the closure of research centers in Nagoya, Japan, and Amboise, France.

As part of the reorganization, Kindler said, Pfizer will step up research efforts in vaccines and antibodies. He also announced plans to exit discovery research in gastroenterology and dermatology. No cut in the firm's $7 billion annual R&D budget was announced.

The company has achieved 2% sales growth in 2006 to $48-4 billion and 4% earnings growth to $15.0 billion, for a profit margin of 31.0%. The company said it achieved sales targets for key products, nine of which logged sales above the blockbuster threshold of $1 billion.

According to Kindler the restructuring measures are a response to a "profoundly changing business environment" in which several of the company's most profitable drugs, including top-selling Lipitor, are scheduled to go off patent in the next five years. The company has a deep pipeline holding more than 200 drug candidates.

(Chemical and Engineering News, 29.1.2007, p. 7)

AstraZeneca Projects Production Job Cuts

AstraZeneca plans to eliminate approximately 3,000 manufacturing-related jobs, or 4-6% of its workforce, over the next three years. The cuts come as part of a productivity program that will also entail closure of unspecified production assets, according to CEO David Brennan. Management remains committed to maintaining a competitive financial performance during a period when the company, as well as the industry, faces challenges posed by patent expirations and pricing pressure," Brennan says. The company reported a 28% increase in operating profit to $8.2 billion.

(Chemical and Engineering News, 12.2.2007, p. 50)

Japanese Firm Tanabe Merges with Mitsubishi Chemicals

Mitsubishi Pharma, Japan's ninth largest drug firm and Tanabe Seiyaku, the 11th largest, have reached a basic merger agreement. Under the deal, Tanabe is taking over Mitsubishi Chemical's Mitsubishi Pharma subsidiary for about $4-3 billion in stock. But Mitsubishi Chemical will acquire a majority stake in the merged entity, tentatively named Mitsubishi Tanabe Pharma.

The companies say the goals of the new firm are to accelerate the research and development of original products, become a more significant international player, and reduce operating costs.

(Chemical and Engineering News, 12.2.2007, p. 18)

William A. Haseltine Words to Drug Industry

William A. Haseltine, the founder and former chief executive officer of Human Genome Sciences took the close look at the inner psyche of the pharmaceutical industry. He took the basic concern over tremendous progress made in innovation over the past 20 years from molecular biology to genomics to stem cells. He did not see anywhere near its potential realized under the current structure.

Human Genome Sciences, known for its role in decoding the human genome, was able to raise billions of dollars to support drug discovery and development, but so far it has not brought a drug to market. Although some of the drugs that Haseltine shepherded through early-phase trials are now nearing commercialization, his experience left him questioning the fundamental structure of the system.

Biotech firms, traditionally viewed as the source of innovation in the industry, can do groundbreaking research, but they don't have the infrastructure to bring drugs to market. That engine of innovation breaks down when big pharma comes in to run late-stage development, Haseltine says.

The problem, he argues, is that the mammoth size of pharmaceutical companies has created an addiction to blockbuster drugs. "Any other industry would be delighted to have a $200 million product with a 70% profit margin," Haseltine points out. "This does nothing for pharma companies."

This dependence on billion-dollar-per-year products creates two fundamental quandaries that keep innovative medicines from reaching patients. First, companies have found that so-called me-too drugs are the only guarantees of broad commercial success. This means that most research dollars go to developing drugs with incremental benefits, rather than to molecules that offer fresh approaches. Yet, even this strategy is getting tough; the me-too options are drying up, and regulatory agencies are becoming weary of iterations on a therapeutic theme.

The second problem, Haseltine says, is that drug companies are trying to fit a small foot into a big shoe by conducting massive clinical trials for a drug candidate that may be useful only in a narrow indication. This "reverse Cinderella syndrome" can be lethal, because it drives companies to either abandon drugs with $200 million sales potential or try to force them to be blockbusters. "The way drugs should be developed initially is for their best and optimal use," he says. "You cannot predict whether it's going to be a blockbuster or a small use."

Haseltine suggests that drugs like Merck's Vioxx 5 and Pfizer's recently withdrawn late-stage cholesterol drug, torcetrapib, might have survived if they had been pursued for a narrow indication-usually the sickest patients-rather than a broad population.

He isn't sure that the addiction can be broken. "The sheer size of the organizations and their sales demand a distortion of the clinical development profile, destroy the relationship between drug discovery and development, and lead to repeated failure," he says. "There's no way around that conundrum."

Meanwhile, big pharma's plan to maintain profits by cutting costs could exacerbate the problem. Haseltine believes the recent slashes in R&D capacity-Bayer and Pfizer are the latest to shed research jobs-are setting the industry up for a fall. As companies look to cut costs, they are increasingly outsourcing research to low-cost centers such as India, China and Eastern Europe.

However, Haseltine is concerned that their approach-handing off research to lower cost centers rather than tying these centers to their own R&D operation is misguided. Low-cost regions, traditionally focused on making generic drugs, are becoming increasingly competitive in the drug discovery arena.

"Pharma, in its efforts to control costs, is building the seeds of its own R&D demise," Haseltine predicts. "They see it as cost-cutting, but they are building their major competitor in the next 10 to 20 years."

The only solution, as he sees it, is to severe the ties between innovation and value creation. To create value, a drug company should focus on what it does best-marketing-and drive innovation by setting up separate R&D houses endowed with their own intellectual property. The drug firm would retain ownership of these entities and some rights to products, but it would let them grow independently.

(Chemical and Engineering News, 5.2.2007, p. 21)

FDA Moves to Improve Drug Safety

US FDA has announced a series of changes to improve the safety of marketed drugs. It will now do a formal reassessment of each new drug 18 months after it is introduced, and it will create a new advisory panel to improve communications about drug safety concerns. The agency will also share information with the Veterans Health Administration on how well patients do on new drugs and medical devices.

(Chemical and Engineering News, 5.2.2007, p. 22)

Indians Have Higher Risk Factors for Cardiovascular Disease

With changing lifestyles and diet patterns, Indians have now become more prone to heart attacks in recent times. A study published in the Journal of American Medical Association (JAMA) on January 17, suggests that Indians and other South Asians have heart attacks at a much younger age compared to other ethnic groups because of higher risk factors for cardiovascular disease.

The research, conducted across five South Asian countries - India, .Pakistan, Bangladesh, Nepal and Sri Lanka - revealed that death from heart attack among people in these countries occurred at least five to 10 years earlier than among people in other countries, including European and West Asian countries and the United States of America.

This analysis, called "Risk Factors for Early Myocardial Infarction in South Asians Compared with Individuals in Other Countries" involved 1732 persons who had suffered heart attacks and 2,204 controls from 15 medical centres, including the St. John's Medical College, Bangalore, All-India Institute of Medical Sciences, New Delhi and the Government Medical College, Nagpur and around 10700 heart attack cases and 12,500 controls from other countries.

The research is part of a larger International study, called INTERHEART (International Heart Study) conducted across 52 countries involving around 30,000 persons. According to the study, the mean age for first heart attack among persons in South Asian countries was 53 years, while it was 59 years for those in other countries.

Protective factors were lower in South Asians compared to other countries, exercise (six per cent in South Asians, 21.6 per cent in other ethnic groups); daily intake of fruits and vegetables (26.5 in South Asians, 45.2 per cent in others) and alcohol consumption once a week (10.7 in South Asian; 26.9 in others).

(The Hindu, 28.1.2007)

Ranbaxy Promoters to Launch Fortis HealthWorld

The Ranbaxy group promoters have decided to enter their foray into healthcare retail through a new entity, Fortis HealthWorld. The newly-launched chain plans to have 1,000 pharma stores, which would have holistic medicines and blood sample collection centres, with value added services in 400 cities over the next five years at an outlay of Rs 800 crore:

The one-stop-shop model is aimed at offering prescription drugs, health supplements, health foods, alternate medicines, home and personal care products and SRL Ranbaxy's collection centre. The new entity would have 250 such stores essentially in northern India, by 2008 end. These will run round the clock and would offer value-added services like prescription reminder service, loyalty programs, OPD appointments in Fortis hospitals and free home delivery.

The entity is looking at setting up at least one warehouse in each state and implement bar coding on all its products, including medicines, to support efficient operations.

(The Financial Express, 7.2.2007)

Rs. 7,786 Crore for Prevention Under AIDS Control Phase-III

The National AIDS Control Organisation (NACO) proposes to spend 67.2 per cent of the total budget on prevention of HIV/AIDS under phase III of the National AIDS Control Programme. This includes targeted interventions and a package of services (excluding anti retroviral treatment). The total requirement for NACP-III, likely to be implemented from April over the next five years, is estimated at close to Rs. 11,585 crore.

Of this, Rs. 7,786 crore is likely to be spent on targeted interventions, blood safety, communication, advocacy and social mobilisation. It includes Rs 2,000 crore for condom promotion alone. The key implementation issues include developing effective partnerships, networking of workplace interventions and clarity of State governments' policies to promote non-governmental organisations and community-based organisation partnerships. Of the total budget, Rs. 1,953 crore is proposed to be invested in care, support and treatment. This includes ART services for which Rs 1,334 crore has been kept aside. Approximately 7.9 per cent - Rs. 910 crore - has been earmarked for strengthening capacities and meeting the administrative cost of implementing agencies at the national, State and district levels.

This component also includes mainstreaming activities. The allocation for information management is 3.1 per cent of the total budget. The concept of knowledge management will be introduced. Given the constraints on availability of good resource persons, NACP-III proposes to identify academic institutions of excellence to carry out research, for which Rs. 360 crore has been earmarked.

An amount of Rs. 576 crore has been earmarked for contingency. The NACP intends creating benchmarks for the package of services which, with the focus on utilisation of services, referrals and counselling, will make performance and effectiveness an integral part of the contract and grant complete autonomy to the implementing agency for ensuring quality and achieving the desired outcome.

The process of implementation and setting benchmarks and making payments, based on compliance with the benchmarks, will be monitored.

(The Hindu, 28.1.2007)

ADAG Allocates Rs 5,000 Crore for Healthcare Sector

The Reliance Anil Dhirubhai Ambani Group (ADAG) has decided to invest over Rs 5,000 crore in healthcare services. The plan includes setting up a chain of medicine retail stores at a cost of Rs 1,200 crore, setting up four hospitals for Rs 400 crore each and two "Medicities" involving initial investments of Rs 2,000 crore each.

The four hospitals will be set up in West Bengal, Bangalore, Delhi, and Mumbai in the next seven years. The company will also bid for healthcare cities coming up at Jaipur and Nagpur, with a focus on medical tourism.

Reliance Health Venture's drug retail foray will roll out nationally very shortly. It will acquire or pick up strategic equity in retail drug chains operating in India and has already bought two small retail chains. Advanced negotiations are on to acquire some big pharma retail chains. Further, it has tied up with 20-odd drug distributors and associations in various parts of the country. Reliance Health Venture has ensured "sole drug distribution rights" with 10 leading pharma companies and is targetting at 1east 30 more companies. It will also set up 25 fully air-conditioned drug warehouses with advanced infrastructure in different parts of the country.

The venture will also take up distribution of medical devices, lifestyle products and over the counter (OTC) drugs. Around Rs 200 crore is likely to be earmarked for giving facelift and creating brand equity for Reliance Health Pharmacies.

(Business Standard, 14.2.2007)

Cancer Study Ordered into Mobi1e Phones

A five year study with more than 200,000 volunteers, has to take place to see if mobile phone users face a greater risk of brain cancer. Professor Lawrie Challis, who chairs the Mobile Telecommunications Health Research programme, is in the final stages of negotiations with the UK government and the mobile phone industry to fund the £3 million study. One European probe has found a link between the risk of brain tumours and using a mobile for more than 10 years.

According to Prof. Challis mobiles could turn out to be the cigarette of the 21st century in terms of the damage it could inflict.

(The Economic Times, 23.1.2007)

Avian Flu Knocks at India's Doors

The highly pathogenic avian influenza (bird flu), caused by the dreaded H5NI virus, is inching closer to India's borders. Confirmed cases of bird flu have been reported from Islamabad, Rawalpindi and Mansehra in Pakistan.

Home-reared chicken and peacocks in these areas have tested positive for H5NI influenza virus. There is, however, no report of this disease in the commercial poultry farms as yet.

Pakistan has formally informed the World Organisation for Animal Health about the outbreak of bird flu in these areas. The infection, believed to have come from migratory birds moving south from Siberia, has resurfaced in Pakistan almost a year after it was successfully controlled in January-February last year.

India has so far been free from this disease and the chances of import of this virus from Pakistan through trade channels are minimal as the country does not buy any poultry products from Pakistan. But the threat of introduction of the infection through the wild birds flying across the country's long border with Pakistan cannot be totally ruled out, animal health experts believe. The danger is all the more real because the infection has been detected in free-range birds, including peacocks, who regularly come in contact with wild birds.

(Business Standard, 15.2.2007)

Dabur Pharma Develops Nanotech-Based Delivery System for Cancer Drug

Dabur Pharma Ltd has launched a novel nanotechnology-based drug delivery system, 'Nanoxel', for the anti-cancer drug paclitaxel. The innovation is in the form of a new polymer based nanoparticle that is water soluble, and to be used in an hour's intravenous infusion.

Paclitaxel, the widely used chemotherapy agent, is currently combined with cremophor, a castor oil based solvent, which leads to many side effects; Dabur's 'Nanoxel', whose drug to polymer ratio is one to half as compared with one to 80 in the case of cremophor, is expected to have far fewer side effects and allow for stronger doses.

The company recently received the US FDA approval for its generic paclitaxel, and will file for European and US approvals for Nanoxel. It hopes to take the product to these markets in 18 to 36 months.

(Chemical Weekly, 16.1.2007, p. 137)

Hetero Drugs Gets SC Nod to Produce 1% Nadifloxacin Cream

Hetero Drugs has got green signal from Supreme Court to manufacture 1% Nadifloxacin cream used for treating various skin ailments. A bench comprising Justice BP Singh and Justice HS Bedi vacated an earlier order of the apex court which had said that the Madras High Court order restraining the company from manufacturing and marketing 1% Nadifloxacin in any form will be confined to its cream type only as Wockhardt has exclusive marketing rights for it. However, the apex court had permitted Hetero Drugs to manufacture and sale other forms of 1% Nadifloxacin. The order was passed taking into account the Bombay High Court order which had refused to grant any interim relief to Wockhardt challenging rejection of its application seeking product patent.

Senior counsel AM Singhvi and advocate Pratibha Singh appearing for Hetero Drugs said that the application of Wockhardt seeking product patent has been rejected by the authority. As it had obtained the exclusive marketing rights under provision of the Patent Act, 1970, on the basis of that application, the restrain order on the petitioner company should be lifted, said Mr Singhvi.

The patent office in its May 18, 2006 order had refused to grant product patent on the ground that the pharmaceutical compositions of racemic Nadifloxacin and its antibacterial activity/property in form of oral, parental and topical form is disclosed in the US Patent.

Hetero Drugs in its application said that Japanese pharmaceutical company Otusuka Pharmaceuticals was given a patent for Benzoquinolizine, also called Nadifloxacin, by the a US patent office. "After the Otusuka Pharmaceuticals patent, the component 1% Nadifloxacin came into public domain and was published, therefore the essential requirement of patentability that is "novelty of invention” was lost forever, said the application of Hetero Drugs. On April 7, 2006, the Supreme Court had modified the Madras High Court order to the extent of manufacture of the Nadifloxacin cream only.

(The Economic Times, 3.2.2007)

Suven Life in Search of Global Partner for its Lead Molecule

Suven life Sciences is engaged in advance discussions with eight global pharma majors for potential in-licensing and co-development of its investigational new drug for Alzheimer's disease. Successful development of a drug for treatment of central nervous system (CNS) disorders like Alzheimer's and mild cognitive impairment (MCI), can mean a global market worth $6-8 billion. Suven has completed the early toxicology studies on its lead compound for the Alzheimer’s disease. According to Venkat Jasti, managing director, the company’s lead molecule on Alzheimer’s disease is to enter clinical trials in the US soon

Suven has entered in to a research and development deal with multinational drug major Eli Lilly recently and is expecting to take several other CNS compounds into the clinical trial stage. The lead compounds include those for the treatment of schizophrenia, parkinson, dementia and obesity. Suven, a pioneering contract research and manufacturing services (CRAMS) organisation, has initiated more than 300 projects under the programme since 1995. Among the projects, 52 are active at various stages of clinical development by the innovators, 26 projects in phase I, 21 projects in phase II and 5 projects are in phase III.

(Business Standard, 13.2.2007)

Lupin Gets USFDA Approval

Lupin has received USFDA’s nod for its Abbreviated New Drug Application (ANDA) relating to anti-depressant Sertraline hydrochloride tablets in multiple dosages. With the latest approval from the USFDA, the company now has 18 USFDA approved ANDAs in its product basket. The company's Sertraline tablets are the AB-rated generic equivalent of global pharma major Pfizer's Zoloft tablets.

(Business Standard, 8.2.2007)

Cipla, Glenmark Get Tentative FDA Nods

Cipla has received tentative approval from the US Food and Drug Administration for AIDS drug lamivudine in tablet form, the US FDA web site showed. The tentative approval is also for zidovudine and nevirapine, also AIDS drugs. Drug maker Glenmark Pharmaceutica1s has received tentative approval for ondansetron hydrochloride tablets, which is used in controlling nausea and vomiting caused by chemotherapy. The drug is the generic equivalent of GlaxoSmithKline's Zofran.

(The Economic Times, 10.2.2007)

Pfizer Mulls Selling Viagra OTC

Pfizer is exploring the idea of selling the Viagra erectile dysfunction drug without a prescription, the company said. An over-the-counter version of Viagra must be approved by US regulators, who would have to determine that patients could self-diagnose the condition and that the product was safe for use without a doctor's supervision.

The drug has been used by more than 23 million men since it was approved in 1998, the company has said. Viagra, along with other erectile dysfunction drugs, has been linked with vision loss in some men. The product labelling also carries a warning it shouldn't be taken with nitrates used to treat chest pain. Viagra's patent is set to expire in 2012, according to a March regulatory filing by New York-based Pfizer.

(Business Standard, 12.1.2007)

Cough, Cold Brands Rules over the Market

Cough and cold formulations sold the maximum among the 10 top selling brands in the domestic market, with total sales touching Rs 270 crore, compared to sales of only one anti-diabetes (insulin) drug reaching Rs 90 crore. The cough and cold segment led by Phensedyl cough linctus and Corex cough syrup was the largest selling category in 2006, followed by pain-killer drug, Voveran. Antibiotic drug Taxim and Vitamin-B complex capsules Becosule are fourth and fifth largest brands in terms of volumes. Cough and cold segment is the largest segment, because most of the brands are available over the counter without need to have a prescription, according to the industry experts. Other top selling brands in the domestic market include Liv-52 by Himalaya, Augmeutin by GlaxoSmithkline, Human Mixtard (insulin) marketed by Abbott and Ranbaxy's antibiotic drug, Cifran.

(The Times of India, 24.1.2007)

Folic Acid Supplements may Give Memory Enhancement

Folic acid supplements may boost brain power in the elderly and could possibly help reduce the risk of dementia, according to the researchers. Brain function, memory and the speed with which information is processed decline as people age but researchers in the Netherlands and Switzerland have found that taking folic acid can help. "We have shown that three-year folic acid supplementation improves performance on tests that measure information processing speed and memory, domains that are known to decline with age," said Dr. Jane Durga of the Nestle Research Centre in Lausanne.

Folic acid is a synthetic compound of folate, a B vitamin found in green leafy vegetables, yeast, liver, beans and in some fruits. British researchers have also shown that folic acid supplements decrease the risk of cardiovascular disease by lowering levels of the amino acid homocysteine, which is thought to damage the inner lining of arteries.

Dr. Durga and scientists at Wageningen University in the Netherlands, who reported their findings in The Lancet medical journal, compared the impact of folic acid supplements to a placebo in a study involving 818 men and women, 50-70 years old. Half of the volunteers were given 800 micrograms of folic acid each day for three years while the remainder received the dummy pill. When the scientists tested the cognitive and memory functions at the end of the study, they found the three-year change was significantly better in the folic acid group.

(The Hindu, 20.1.2007)

Ministry Moots 30% Royalty For Scientists

The Ministry of Science & Technology will shortly recommend the Finance Ministry to consider grant of at least 30% of royalty share to the scientists for the innovations in the 2007-08 Budget. Only those innovations whose commercialisation has taken place shall be considered, said Union Minister for Science & Technology, Kapil Sibal.

Speaking at a conference organised by industry body Assocham, Sibal said, “this is necessary to encourage commercialisation of innovations, increase domestic production and exports and protect interests of the scientists." Moreover, the government would enact a legislation similar to Bayh-Dole Act of US to protect innovations.

Ministry of Science & Technology Secretary T Ramasami added that the ministry would undertake all possible initiatives to release productive grants to the domestic research institutes such as Council of Scientific and Industrial Research (CSIR) and others. This would encourage the institutes to innovate which would later increase domestic production and exports.

(The Economic Times, 17.12007

Nicholas Piramal, Eli Lilly Enter in Drug Development Deal

Nicholas Piramal India (NPIL) has entered into a patented, pre-clinical drug development, agreement with US-based Eli Lilly, to conduct non clinical studies and human clinical trials up to Phase III, for one Lilly drug molecule for metabolic disorders, with a provision to work on four more molecules. The deal entails milestone payments of $100 million for the first drug, plus royalties, when the drug is eventually commercialised.

The drug being outlicensed by Eli Lilly could be for diabetes, considering that most drugs for metabolic disorders also work for diabetes, it has been learnt. The drug is expected to be commercialised by 2010, provided it gets through the various phases of human trials.

Advinus Therapeutics, promoted by the Tatas, entered into a discovery and clinical development collaboration with US-based Merck & Co. Inc to develop drug candidates for metabolic disorders. To begin with Merck would out license two drug targets to Advinus, for which the latter will receive a milestone payment of $74.5 million per target.

In all, the collaboration will cover a basket of 10 drug candidates over an unspecified period. Advinus will also be eligible for royalty payments when the medicines are finally commercialised. Other, Indian companies; Ranbaxy and Torrent Pharma, have collaborative drug research agreements with GSK and AstraZeneca respectively.

(Financial Express, 18.1.2007)

Dr Reddy's to Set Up Life Sciences Research Institute in Hyderabad

Dr Reddy’s Laboratories along with the Andhra Pradesh government and the University of Hyderabad (UoH) is setting up a new institute in Hyderabad for conducting industry relevant research in life sciences. Research activities at the Institute of Life Sciences (ILS) are expected to commence by April. The project will require an investment of over Rs 50 crore, according to Dr K Anji Reddy, chairman of Dr Reddy's Labs. The state government and DRL have invested about Rs 20 crore in the first phase.

The University of Hyderabad has provided 20 acres for setting up the institute. "The institute will help integrate interdisciplinary sciences, especially' biology and chemistry, and will focus on developing innovative life sciences solutions.

Set up on the lines of the Scripps Research Institute, in San Diego, ILS will have an active intellectual property management cell for protecting its research results and filing patent applications. According to Mr Venkateswarlu, director of ILS, the institute has 32 research labs and 12 support labs.

(The Economic Times, 30.1.2007)

Zanotech Kicks off Cancer Drug Research

Zenotech Laboratories is undertaking research and development to bring out a new biological entity to treat cancer. Its first new biological entity, a monoclonal antibody developed in house for cancer especially targeted towards common cancers like head and neck, is likely to enter clinical development in 2007 after necessary toxicity and animal studies.

The company is currently working on two projects for generating new monoclonal antibodies for two specific receptor targets in lead optimization stage for cancer. The company plans to out license the drug in Phase II stage for further development, said Jayaram Chigurupati, Chief Executive Officer, Zenotech Laboratories.

He said Zenotech plans to develop a total of 40 ANDAs, which includes 14 with Ranbaxy as per an agreement for developing and marketing 14 specialty injectables (ANDAs) for US and Canada. At present the company has 10 injectables in oncology and five in anesthesiology developed and marketed in India. Zenotech is the first Indian company to develop GMCSF and IL-2, two generic biologicals. G-CSF and GM-CSF has been launched in India and IL-2 has completed clinical trials, which is awaiting approval from DGCI. Three other generics biologicals are also under development The company has technology skills in developing generic monoclonal antibodies, and has developed generic rituximab, used to treat a type of cancer called non-Hodgkin's lymphoma. It is awaiting Drug Controller General of India (DCGI) approval for clinical trials in India. Four other generic monoclonal antibodies are under development phase. The company has two R&D facilities, one in Hyderabad and the other in Princeton, USA.

(Business Standard, 15.2.2007)

Patent Grant to NCEs not TRIPS Compliant, Says Report

The technical expert group headed by RA Mashelkar, in its recent report, has suggested that limiting the grant of patents to only new chemical entities would not be TRIPS compliant, while exclusion of micro-organisms per se from patent protection could be "violative" of the international charter.

The group, in the report said granting patents to only new chemical entities (NCEs) or new medical entities (NMEs) and excluding other categories of pharmaceutical inventions, was likely to contravene the mandate of the international charter to grant patents to all "inventions".

It said drug discovery research was still finding its feet in India. Though many companies were investing, it would be at least a decade before a critical mass was in place and results started accruing. Thus, restricting patentability to just NCEs would mean that most of the pharmaceutical product patents would be owned by MNCs and not by domestic pharma companies.

There was a need to form strict guidelines for examination of the applications involving micro-organisms from the point of view of substantial human intervention and utility. Its exclusion from patent protection is not in sync with TRIPs, the report said.

The experts have suggested that the India Patent Office make an effort to prevent grant of frivolous patents and their 'ever-greening' by preparing strict guidelines.

These recommendations are, however, not legally binding on the government. Whether to include the suggestions in the policy solely depends on the government, added the analysis.

(Financial Express, 15.1.2007)

Ranbaxy, GSK Extend R&D Pact

India's largest drug maker Ranbaxy Laboratories has expanded the scope of its existing research alliance with global pharmaceutical major GlaxoSmithKline (GSK) to include a wide range of therapeutics such as anti-infectives, metabolics, respiratory and oncology products. Every successful product out of the research alliance could fetch Ranbaxy $100 million (Rs 450 crore) as milestone payments.

The new milestones and royalties will apply to future drug discovery programmes and also the two ongoing programmes at Ranbaxy, which had begun under the original agreement with GSK, Ranbaxy CEO and MD Malvinder Mohan Singh said.

Indian companies are much sought after for joint drug research programmes. All the major research intensive drug companies such as Dr Reddys, Glenmark and Nicholas Piramal have drug R&D agreements with foreign multinational drug firms.

Under the original agreement signed in 2003, Ranbaxy were to conduct the optimisation chemistry required to progress drug leads to the stage of candidate selection. Under the new agreement, Ranbaxy will advance leads beyond candidate selection to completion of clinical proof of concept.

GSK, thereafter, will conduct further clinical development for each programme and take resulting products through the regulatory approval process to final commercialisation.

Ranbaxy could receive milestone payments for a product it developed. and subsequently launched by GSK in multiple indications and up to double digit royalties on worldwide net sales. Ranbaxy will retain the right to co-commecialise the products in India, the company stated.

(Business Standard, 7.2.2007)

India Draws Attention of Global Clinical Research

India is fast turning into an important centre for global clinical research - a fact that is reflected in the presence of multinational drug majors like Pfizer, Johnson and Johnson, GSK, Merck, Eli Lilly, and Novartis.

All big companies today either own clinical research facilities (such as Pfizer and Eli Lilly), or outsource clinical research services from contract research organisations (CROs) in the country.

The shift in MNC interest towards India for clinical development was not momentous. The rising costs of clinical development in advanced countries, and the dwindling numbers of money-spinning drugs (resulting in reduced profits) has prompted them to go in for outsourcing.

India's revised patent laws (that provide protection for products), introduction of good clinical practices, rich patient pool, talented medical faculty, and the data processing infrastructure for bioinformatics has helped India make the most out of the outsourcing opportunities.

According to industry estimates, India can attract between 5-10 per cent of the global contract research outsource market over the next five years. This includes chemistry services, toxicology services and clinical research activities. This translates into a business worth $0.8-1.7 billion by 2008, and $1-2 billion by 2010. Approximately, 40-50 per cent of this would come from clinical research.

An Ernst & Young study, commissioned by industry body FICCI, says that India will contribute 1,00,000 patients towards clinical research, and will need not less than 3,000 clinical trial sites, over 50,000 clinical research professionals and a regulatory body that can handle over 400 clinical trial applications.

However, all is not well with this emerging business opportunity. The Drugs Controller General of India (DCGI) is concerned over the mushrooming of CROs in the country. The Ministry of Health and Family Welfare, under whose administrative control the DCGI-functions, has hinted at formulating an accreditation system for CROs.

Concerns have also been raised about the delay in regulatory approvals, deficiencies in the functioning of the ethics committees, and the overall quality of clinical trials.

(Business Standard, 7.2.2007)

DCGI Makes Effort for Fast Clearance of Global Clinical Trial

The Drugs Controller General of India (DCGI) in order to minimize the delay in sanctions of global clinical trials has announced a checklist for submission of applications for global clinical trials, and has assured that those applications which comply with the specifications in the checklist will get fast track clearance. 'The attempt is the first among a series of measures planned by the Ministry of Health and Family Welfare promote clinical research activities the country.

The Ministry is in the process of framing a law that would ensure proper regulatory control over experimentation on human subjects. The law, which is at the drafting stage, is aimed at allaying fears among the public about making them "guinea pigs" through human trials. It will also protect the interests of human subjects, and also make sure that the benefits of clinical research reach the common man at a reasonable cost.

The clinical research community feels that proper government regulation is essential for the sustained growth of the industry. They have demanded the setting up of a central committee of experienced researchers for policy implementation, comprehensive policy guidelines for clinical trials, rules and regulations for toxicology studies and a host of fiscal incentives.

(Business Standard, 7.2.2007)

Intas Biopharmaceuticals Ties up with US Company

The Intas Biopharmaceuticals Ltd, a group company of Intas Pharmaceuticals Ltd, has entered into a joint venture with Progenetics LIC, a US based company that has created transgenic animals that produce “Factor DC, a drug used for treatment of hemophilia-B, in milk.

Announcing the tie-up, Intas Biopharma Managing Director, Dr. Urmish H. Chudgar and the Virginia-based Progenetics CEO, Dr. Julian Cooper, said that the joint venture company would invest Rs. 13 crore for development of the drug and subsequent clinical trials that may last two to three years. At present, this drug is imported from the US where its market is worth US$300 mn.

(Chemical Weekly, 23.1.2007

RLS Eyes $1 Billion through Biopharma

Reliance Life Sciences (RLS) has decided that the company was targeting revenue of $1 billion by 2011 through the launch of bio-pharma product including pharma proteins, biosimilars, novel proteins, monoclonal antibodies and siRNA in the regulated markets of the EU and the US. The combined market for biosimilars in these markets is expected to touch $21 billion by 2015.

RLS has acquired GeneMedix in December 2006. 'The GeneMedix acquisition has given us a platform for a biosimilar entry into the EU," says KV Subramaniam, president and CEO, RLS. "Both the companies have complementary products and have synergies with regard to their facilities," he added. RLS, which recently entered the Indian market with five plasma protein products, has several products under development in areas like specialty plasma proteins and biosimilars. GeneMedix has a range of products including EPO (erythropoietin, used in chronic renal failure), G-CSF (Granulocyte Colony-, stimulating Factor), IFNα (Interferon-alpha) and insulin. 'The global sales for EPO alone is $1 0 billion while that of G-CSFis $3 billion," Subramaniam said. Although there were global players like Amgen, J&J and Roche vying for the EPO pie, and companies like Amgen for the GCSF market, RLS would leverage its low-cost manufacturing base in India to garner market share.

(The Financial Express, 8.2.2007)

Ranbaxy Ties up with Zenotech

Ranbaxy Laboratories Ltd had signed an agreement with bio-pharma firm Zenotech to develop and market its bio-similar product for chemotherapy-induced infections (neutron-penia). The world wide market for neutropenia treatment is over $4 billion, while the global market for the drug being developed is in the range of $1.6 billion.

The product is used to prevent infections from chemotherapy, which crop up due to reduced white-blood cells. Under the agreement, the two companies would exploit their resources to introduce the product for global marketing, beginning with markets in the EU and eventua1ly in America. The products will be manufactured in Zenotech's facility in Hyderabad, which are approved both by the USFDA and the European Union.

Biosimilars are generic versions of bio therapeutics using recombinant DNA technology. So far, no Indian bio-similar product has been launched in the EU due to the substantial investments involved in clinical trials and the regulatory expertise required. Both these aspects pose significant barriers to entry, Ranbaxy said in a statement.

"Ranbaxy would pool its regulatory and front-end infrastructure with Zenotech's expertise to develop and manufacture bio-similar products. It also strengthens our existing alliance with Zenotech for oncology products," Ranbaxy's chief executive officer Malvinder Mohan Singh said.

"G-CSF will 1ead the way for the development of other bio-similar molecules within our portfolio," chief executive officer of Zenotech Labs Jayaram Chigurupati said.

(The Financial Express, 8.2.2007)

Pharma Industry Needs SEZs

Special Economic Zones (SEZs) are of particular interest to India's pharmaceutical industry, both in absolute terms and in relation to the competition, particularly from China whose meteoric rise as an economic superpower in Asia can be attributed at least in part to its foresight in setting up SEZs some 30 years ago. Coming bundled, as they do, with an attractive tax environment, world-class infrastructure, decentralised administration, and a liberal labour environment, China's SEZs have, overall been a resounding success. The first SEZ, a sprawling 100,000 acre complex in Shenzen, has alone managed to attract over $30 billion in direct investment and the 49 state level zones across China account for more than 70% of all FDI enterprises in the country. Beijing is fast becoming China's leading biotech centre, boasting several biotech parks designed to meet US FDA standards.

The pharma sector in China recorded an annual growth rate of l6.7% between 1978 and 2003. Contribution of exports (nearly $14 billion) in China's pharma industry was close to 29% in 2005. Already a major competitor to India in the export of APIs (active pharmaceutical ingredients), China is set to run India close in other pharma segments as well. It's making rapid strides in biotechnology, for instance, thanks to a combination of beneficial policy changes, increased programme funding, low labour costs and reorganisation of the science and technology system. Chinese biogeneric manufacturers already market 361 recombinant biogenerics and 25 biotech drugs. China currently produces eight of the world's top 10 genetically engineered drugs or vaccines. The revenue 'from biopharmaceutical production in China reached levels of $4.2 billion in 2005, up from $860 million in 2000, and it's growing at 20% to 30% per year.

India is the world's fourth largest pharmaceuticals producer with an 8% share of global production by volume and 1.5% share by value. The industry produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing process and has also developed excellent Good Manufacturing Practices (GMP) compliant facilities for the production of different dosage forms. India is home to the largest number of pharmaceuticals plants (61) approved by the USFDA outside the US, and the country accounts for the largest number of annual drug filings with the USFDA. Export growth over the last five years has been over 20%, with the US being the largest market. In biotechnology, India has already been identified as one of the emerging leaders in the Asia-Pacific region. Several Indian companies have already started producing biotechnology-based drugs for diseases such as cancer and diabetes.

Given our acknowledged strengths in the pharma industry, it's imperative that we step up the momentum, particularly in manufacture and exports. In this context the importance of SEZs cannot be over emphasised, from the point of view of concentrating scares management and infrastructure resources on an effective programme rather than spreading them over too thinly. The benefits of SEZs can be optimised through active linkage programmes, adequate social and environmental safeguards, and private sector involvement in their development. Other requisites for a successful SEZ such as excellent connectivity, efficient communication and power facilities and finally good social infrastructure need to be ensured.

In sum, the Indian pharma biotech industry stands to be well served by SEZs. They will boost manufacturing exports, attract much needed FDI, increase foreign exchange earnings and create more jobs. Overall, the SEZs are sound in principle and, if well executed, could fetch considerable dividends over the long run.

(Based on an article by Kiran Majumzar Shaw, CMD, Biocon Ltd., Published in The Economic Times, 15.1.2007)

Reliance Life Set to Invest Rs 278 Cr in GeneMedix

Reliance Life Sciences is investing Rs 278 crore in GeneMedix, the UK based company over five years to conduct clinical trials and launch two products under development. Reliance Life had acquired the UK-based biotechnology company recently.

The acquisition of GeneMedix, a distressed company with over Rs 43 crore debt offers Reliance Life an opportunity to enter the European biopharmaceutical market. It will also enable Reliance to leverage the therapeutic proteins under development with a complimentary product portfolio of GeneMedix.

GeneMedix has a manufacturing facility at Tullamore in Ireland, which has good manufacturing practice (GMP) accreditation by the Irish Medicine Board. At present, GeneMedix has two lead biosimilar (biogeneric) products under development. The erythropoietin (EPO) product, is now undergoing limited Phase III clinical trials in Europe. The product is likely to be launched in 2008. Its second product Granulocyte Colony Stimulating Factor (GCSF), used as an adjunct treatment with chemotherapy for cancer, would be entering the clinical trial stage later this year.

Reliance intends to introduce EPO in India, following concurrent clinical trials. Reliance also has a GCSF product under development. The global market for EPO and GCSF are estimated to be $ 10 billion and $ 3 billion respectively.

(Business Standard, 8.2.2007)

Reliance Life to Start Exports to S Asia

Reliance Life Sciences, which launched five plasma protein therapeutic products in the Indian market a year ago, will soon start exports to the South-East Asian and South Asian markets.

Reliance Life Sciences currently markets plasma protein products AlbuRel, ImmunoRel, ReliSeal, HemoRel A and ReliPlasma in the domestic market, mainly through direct supply to hospitals. Currently, Reliance has a pilot-scale manufacturing facility and is constructing a large-scale world class facility - to be operational this year.

Reliance Life plans to launch about 40 to 50 products in various therapeutic categories of speciality plasma proteins, biosimilars, novel proteins, monoclonal antibodies and siRNA molecules.

(Business Standard, 8.2.2007)

Dupont Plans R&D Center In India

DuPont plans to build a $23 million research center in Hyderabad, India, to accommodate more than 300 scientists and other employees. The firm has signed a memorandum of understanding with ICICI Knowledge Park for a long term lease that will allow the firm to construct an R&D facility on 15 acres of park land. DuPont expects the facility to be fully operational in 2008. Scientists at the center will initially focus on molecular biology, bioinformatics, and polymer synthesis.

(Chemistry and Engineering News, 5.2.2007, p. 17)

WARF Eases Stem Cell Patent Enforcement

The Wisconsin Alumni Research Foundation (WARF) has announced three policy changes to the licensing terms covering the set of patents it holds on primate embryonic stem cells. The policy changes come as the U.S. Patent & Trademark Office is reviewing the validity of the patents. The first policy change will allow industry-sponsored research to be done at academic or nonprofit institutions without a license from WARF. A company will still need to obtain a license once the work moves into its labs or the work is being developed into a commercial product. Another change in policy will allow researchers to transfer WARF cells to others for free. Previously, such transfers required a license. The final change clarifies WARF's position related to the California Institute for Regenerative Medicine (CIRM), a nonprofit, grant making organization set up to distribute stem cell research funds created by the state's $3 billion bond initiative. The change clears CIRM to make grants to and collect funds from its grantees without remitting any payment to WARF.

(Chemical and Engineering News, 29.1.2007, p. 31)

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