Mr Sanjeev Gupte – Head of International Marketing accepting award from Mr Christopher Forbes, Vice Chairman of Forbes Asia, Mr Albert Teo, CEO of Amara Sanctuary Resort Hotel and Dr Loo Choon Yong, Chairman of Sentosa Leisure Group for The Best Pharmaceutical Company Under A Billion in the Region's Top 200 Asia Small and Mid Size companies.

Mr Sanjeev Gupte – Head of International Marketing accepting award from Mr Christopher Forbes, Vice Chairman of Forbes Asia, Mr Albert Teo, CEO of Amara Sanctuary Resort Hotel and Dr Loo Choon Yong, Chairman of Sentosa Leisure Group for the Most Profitable Company Under A Billion in the Region's Top 200 Asia Small and Mid Size companies in the overall category.

New Delhi, Oct 4 (PTI)

As many as 17 Indian firms including Dabur India, Pantaloon Retail, Cipla Healthcare and Asian Paints have been named in the latest Forbes list for top 200 Asian companies with sales of less than a billion dollars.
The latest Forbes 'Asia's 200 Best under a Billion' list included companies from 14 countries from Asia and the Pacific region. Besides India, the list covered China, Australia, Japan, Singapore, South Korea, Taiwan and New Zealand.

The other Indian companies named in the list for 2007 are Bharat Bijlee, Divi's Laboratories, Elder Pharmaceuticals, Era Infrastructure & Engineering, ICSA, Infotech Enterprises, IPCA Laboratories, NIIT Technologies, NRB Bearings, Nucleus Software, Patni Computer Systems, Praj Industries and Thermax.

The list focuses on companies with less than one billion dollars in sales and which have recorded consistent growth in sales and profits over three years. These names were selected from over 22,500 publicly listed entities in the region.

However, the number of companies named in the list this year are less than in last year's list which had included 23 companies from the India. The outgoing companies include -- Bajaj Hindustan, Balrampur Chinni Mills, Bharat Forge, Sesa Goa and Cadila Healthcare.

Cipla, classified under the personal care products industry has the highest market value of USD 3.45 billion. It is followed by Asian Paints with USD 2.20 billion and Dabur India (personal care products) with USD 2.13 billion.

In terms of sales, Asian Paints (USD 855 million) and Cipla (USD 833 million) have found a place among the leaders. PTI

Y. K. HAMIED

The Indian Patents Act of 1972 that granted independence to the Indian pharmaceutical industry was undone by the draconic amendment of March 2005, which back-dated product patenting to January 1995. The 1972 legislation was prompted by national interest; 2005 by international pressure. Each country has its own specific need-based patent laws, and has to decide its own destiny, says Y. K. HAMIED.

I was 11 when India had its “tryst with destiny”. I remember it was a day of great celebration at Cipla, the company my father, Dr K. A. Hamied, had set up. The company was just a year older than me. I believe, in retrospect, that all three — the country, the company and the little boy — shared a great optimism about the future.

Sixty up-and-down years later, I seem to be the only one growing old. At 60, our country is a purposeful young man, who the strong are eager to befriend and the weak look up to with hope and trust. It is a matter of great pride to read about Indians doing so well globally. Some 20 years ago, an Indian company taking over an international company would have made headlines. Now India seems to have developed a global reach. and the pharmaceutical industry is no exception.

The country may have gained independence in 1947 but the Indian pharmaceutical industry was still very dependent on imports. There was hardly any domestic industry to talk about. Most of the drugs we needed were controlled by multi-nationals. Today, the Indian pharmaceutical industry ranks fourth in the world in terms of volume, with a 12 per cent share. In terms of value, the domestic industry alone is 13th, with a 1 per cent share. The total worth of the Indian pharmaceutical industry is estimated at $10 billion.

In the early days of independence, India had no say in the availability and affordability of drugs. Today, we are in the happy state of being able to produce most of the drugs and active pharmaceutical ingredients (API). From abject dependence on imports, India has grown to be one of the top four producers of API.

As much as 55 per cent of formulations and 45 per cent of API produced in India are exported. The industry is indeed booming, and 15 of the 20 largest pharmaceutical companies in the world have a presence in India. The Indian domestic industry is expected to touch a market size of $10 billion by 2007 from $6.5 billion last year. From a position of dependency, when and how did this transformation happen?

‘Patenting' Independence: 1972

I was too young to understand the significance of the nation gaining Independence. But I was overjoyed when the Indian Patents Act of 1972 granted independence to the Indian pharmaceutical industry. I had joined Cipla in 1960 as a fresh employee in the research department. It did not take me long to realise that there was nothing much that Cipla or any other Indian pharmaceutical company could do.

Our hands were tied by the then patent law that put the interest of foreign monopolies before the health of millions of suffering Indians. April 20, 1972 was a red-letter day for India. It was the day when the Patents Act (Act 39 of 1970) came into force, replacing the Indian Patents and Designs Act of 1911. The new Patents Act abolished product patents and allowed process patents for seven years only.

Come to think of it, the rationale behind the patent amendment of 1972 was not very different from the rationale behind the Independence movement. Our freedom-fighters essentially fought for the right to decide what was best for our country rather than be dictated to by foreign powers.

The Indian Patents Act of 1972 granted the pharmaceutical sector the right to produce any drugs the country needed. It did away with the shackles imposed by monopoly. It refused to let multinational corporations (MNCs) wear the noble garb of intellectual rights.

Recently, I was trying to explain the significance of this old law to a group of young IT professionals. I asked them to imagine the plight of the Indian IT industry if Microsoft and other software giants were to prevent any Indian from doing any developmental work on their software platforms.

The students rightly thought this would be a catastrophic scenario. What the 1972 amendment to the patent law did was avoid a healthcare catastrophe. The industry then converted it into an opportunity. It was the best thing that ever happened to safeguard the country's health.

In 1971, MNCs had an over 70 per cent share of the Indian pharmaceutical industry. In 2007, in a reversal of roles, Indian companies commanded 83 per cent. In 1971, Alembic was the only Indian among the top 12 companies in the Indian pharmaceutical market. In 2007, there are only three MNCs in the top-12 list.

It is one thing to import formulations in a ready-for-sale state and another to indigenously produce the APIs required for making these formulations. The capacity of the industry to produce APIs for its own consumption and for exports is a good measure of its strength and maturity. In 1974-75, 24 years after Independence, the industry produced APIs worth Rs 900 million. In 1996-97, 24 years after the Patents Act of 1972, API production was worth Rs 21,860 million and in 2006-2007 it was Rs 98,900 million, approximately.

The story is the same with drug formulations. In 1974-75, total domestic sales of formulations was worth Rs 4,000 million. In 1996-97, the figure had jumped to about Rs 20,000 million, and it crossed Rs 65,000 million in 2006-2007.

Some of India's leading pharmaceutical companies are acquiring companies in Europe, the US and other countries. Many more are getting into marketing and technological tie-ups. Pharmaceutical mergers and acquisitions fail to surprise us any longer.

Pharmaceutical business models are changing. The world is now discovering India as a preferred place for clinical research. In more ways than one, the industry appears set to keep up its growth and progress, but for the 2005 Act.

Patents and the national interest

The pragmatic Patents Act of 1972, that led to tremendous growth, was undone by the draconic amendment to the Act in March 2005, which back-dated product patenting to January 1995.

If 1972 was motivated by national interest, 2005 was prompted by international pressure, by an ill-perceived need to “belong” to the international community. The Patents Act 1972 resurrected a flagging domestic pharmaceutical industry. This Act had a much wider purpose; to help the Indian who had to fight TB, diabetes and a multitude of diseases with affordable medicines.

Every country has its own specific need-based patent laws, which are national laws. There is no harmonisation in patent laws of different countries. Each country has to decide for itself its own destiny.

Today we have a population of over 1,100 million. The diseases that used to worry us the most are still around. There is the additional scourge of HIV/AIDS. Millions of Indians need medicines. Most of them cannot afford to pay high prices.

Going by global experience, product patents that are now again enforced, can only lead to monopolies and these, in turn, to high prices. Africa and the AIDS issue of 1990-2000 is a clear example.

I sincerely believe that an inventor holding a valid patent should be suitably rewarded. In recent years, India itself has embarked towards increasing and protecting intellectual property and the science that is being developed by our scientists. India must protect its traditional knowledge base and see to it that frivolous patenting is not done — examples of these are innovations in turmeric, basmati and even yoga.

India needs to build in enough safeguards even in our current patent law. Perhaps in our haste to join WTO, we neglected many important issues — for instance, the real meaning of the 10-year transition period given to India and as to why India, specifically for the purpose of patents, was not included in the list of least developed countries.

The Indian pharmaceutical industry has come of age. It has taken its time to reach where it is today. But it has lost no time to realise and act on its responsibilities to the less fortunate. We claim no halo; we are in business too. But we have a conscience, and we are proud of it.

(The author is Chairman and Managing Director, Cipla.)

NEW DELHI: It's a potent cocktail of rivalries involving pharma companies and NGOs. It has now emerged that Aids Healthcare Foundation (AHF), the US-based NGO that accused Cipla of over pricing anti-AIDS drug, Viraday, in India is part funded by American anti-AIDS drug maker Gilead and the NGO's treasurer is a senior Gilead executive.

This is largely the reason why foreign and Indian NGOs such as Medicine Sans Frontier (MSF), Delhi Network of Positive People (DNP+), Indian Network of Positive People (INP+), Sahara and others refused to be part of AHF's anti-Cipla campaign.

Cipla had refused Gilead's offer to sell the latter's anti-AIDS drug Viread under a licensing agreement. Cipla is also the only Indian company opposing Gilead's patent application for its blockbuster anti-HIV drug Viread in India. The hearing for the patent case of Viread is due in October.

Gilead has entered into a contract with 10 Indian companies to sell Viread in India and other countries. These companies, which include Ranbaxy, Alkem, Aurobindo, Emcure, Hetero Drugs, Matrix Laboratories and Shasun Chemicals & Drugs among others, are not opposing Gilead's patent application.

Says a head of an NGO, who did not participate in the anti-Cipla campaign: “There is a conflict of interest in the campaign. AHF is funded by multinational pharma companies. A senior Gilead executive is one of the directors of AHF and the campaign choose to target Cipla for over pricing at a time when it is fighting Gilead's patent case in India. There is a discomfort and many civil society groups decided to stay away from the campaign.”

Following the campaign, the Monopolies and Restrictive Trade Practice Commission is set to probe Cipla's pricing of the anti-HIV drug Viraday in India. AHF Asia Pacific bureau chief Chinkholal Thangsing, who is spearheading the campaign, however, dismissed the allegation. “AHF is not for sale to Gilead or any other company.

We differ with Gilead on many issues and have expressed that concern publicly and privately. We are opposed to Gilead's application for a patent in India. Gilead was not involved in AHF's decision to run advertisements asking Cipla to bring down prices in India,” he said.

When contacted, Gilead senior V-P and general counsel Gregg Alton, who is also the treasurer of AHF told ET: “Gilead is not funding or in any way involved with AHF's campaign. As a board member of AHF, I was made aware of this campaign, but neither I nor Gilead have any involvement in it.” Gilead Foundation, a non-profit entity of the drug company Gilead, provided a grant of $7,50,000 to AHF in 2006 for a program to support HIV patients in Uganda. Similarly, the grant supports work to direct resources for education, outreach and infrastructure to AHF programs in India and Southeast Asia, he added.

A Cipla official said, “Given the context, AHF's campaign is motivated by MNCs and there is a straight forward agenda to malign Cipla. From where does AHF get the money to pay for such huge advertisements? We are suing AHF for the false allegation.” Dr Thangsing said AHF targeted Cipla as it is the leader amongst the generic AIDS drugs manufacturer and charges the highest prices among generic companies.

Cipla and MSF have confirmed that the Indian company had indeed offered to sell Viraday at Rs 21,000 in Africa, as recently as June 2007, while it sells the same drug for Rs 54,000 in India, he alleged. AHF has so far spent $25,000 for the campaign but the money has come from AHF's own fund, he said.

Cipla’s paediatric version of triple-combination AIDS drug ‘Triomune’
can now be purchased by the US$15-bn PEPFAR global-initiative to treat the illness. This follows the tentative approval that paediatric Triomune got from the US-FDA. Children below 12 years and infected with HIV/AIDS can now receive treatment under the initiative. It is the first fixed dose paediatric AIDS drug to get onto the PEPFAR programme, according to Mr. Amar Lulla, Cipla’s Chief Executive Officer.

In 2003, the US President, Mr. George Bush had mooted the President’s Emergency Programme for AIDS Relief (PEPFAR) over a five-year period to tackle the illness.

‘Triomune’ is a fixed-dose tablet that combines three AIDS medicines - lamivudine, stavudine and nevirapine. Lamivudine is the generic ingredient in GlaxoSmithKline’s AIDS medicine ‘Epivir’, stavudine is Bristol-Myers Squibb’s ‘Zerit’ and nevirapine is Boehringer Ingelheim’s ‘Viramune’.

There is a baby and junior version of ‘Triomune’. The baby version of ‘Triomune’ will be given to the PEPFAR initiative at a cost of about
US$4.5-5 per month. The medicine is sold in India at US$7.5 (Rs. 310) per month. In India, the drug is sold in the private market, while the PEPFAR initiative involves structured-sourcing that ensures volumes. It also guarantees API prices, Mr. Lulla said, explaining the price difference.

AIDS drugs for children have been a concern, as companies had focused their energies only on adult versions of the medicine. These used to be crushed and given to children. Paediatric Triomune can be swallowed or dissolved in water and can be given to patients weighing as little as 5-kg.

The company will be able to replace all its CFC products with hydrofluroalkaline technology by early 2008

Cipla Ltd is all set to replace its entire range of products containing chlorofluorocarbons (CFC) two years ahead of the Montreal Protocol ban deadline.

The move is significant because Cipla has a 70% share of the inhaler market in India. In addition, it is the third largest company, by sales, in the anti-asthmatic inhaler drug market, behind GSK Plc. and AstraZeneca Plc. Cipla sells these products in 40 countries, including Australia, New Zealand and Latin America.

Cipla chairman Y.K. Hamied told Mint that the company will be able to replace all its CFC products with hydrofluroalkaline (HFA)—or dry powder drug substance—technology by early 2008.

Two of Cipla's major products, the Rotahaler and the Asthalin inhaler

An international agreement—the Montreal Protocol on Substances that Deplete the Ozone Layer—signed by more than 160 countries including India, has called for a general ban on CFC production as it is a major cause of global warming. While the deadline to comply with the agreement was 2005 for developed countries, it has an extended deadline of January 2010 for developing countries including India. According to Hamied, Cipla has already developed the necessary technology for the conversion and some of the products are completing clinical trails within India and overseas.

“Though the technology shift will cost us more, we are committed to comply with the international norm as early as possible,” he said, noting that the company has already launched two CFC-free products in the domestic market.

“The technology change in our major inhaler manufacturing plants is almost complete now,” Hamied said. Cipla currently produces inhaler drugs in factories located at Goa, Kurkumbh, Sikkim and Baddi.

A senior official from Cipla, who did not want to be quoted, said: “Though there were reports that the companies who comply with the deadline early will be eligible for industrial incentives from respective governments, we haven't heard of any such benefits so far from the government.

“There will be a slight increase in prices of the new products due to the high cost (about 15% to 20% more) in the new technology. We hope the National Pharmaceutical Pricing Authority (NPPA), the drug price control body in India, would permit the cost escalation,” he added.

Two drugs—Salbutamol and Theophylline, which are used in anti-asthma inhalers—fall under the Drug Price Control Order. An NPPA official, who also didn't want to be quoted, said the department has already worked out some solution to allow different pricing for CFC and non-CFC inhalers in India.

The NPPA notification to this effect will be out soon, he added.

The anti-asthma segment is growing at more than 20% per annum, mainly due to an overall increase in pollution that is leading to a spurt in the number of asthma cases.

One of Cipla's major products, the Asthalin inhaler, has annual sales of at least Rs40 crore, with a domestic annual growth rate of at least 30%.

In the anti-asthma segment, inhaler therapy is preferred to tablets since the dose required is about one-tenth of an oral dose. The inhaled drug directly goes to the lungs, often giving instantaneous relief.

About 25% of Cipla's total revenue comes from anti-asthma drugs. Cipla has also recently developed a new variety of inexpensive Rotahaler and spacers.

The Rotahaler is based on dry powder inhalation, compared with regular inhalers which use propellants for the drugs.

The spacer is a plastic device that helps in slow inhalation of drug from the inhalers. The company has applied for international patents for both these products.

Our Bureau

Mumbai, Aug 24 Cipla is set to undertake a Rs 950-crore capacity expansion over the next two years, Chairman and Managing Director Dr Y.K. Hamied told shareholders.

The investments will be made in three formulations facilities at Sikkim, Goa and Indore that would make the finished forms of medicine.

About Rs 180 crore will be invested in a tablet and injectible facility in Sikkim, Rs 400 crore will go towards the Goa plant that would make aerosols, capsules and tablets, while Indore will involve an investment of Rs 350 crore and will make form-filled sealed units, among others.

The company has, in the last two years, invested about Rs 800 crore in capacity expansion, he said.

The Mumbai-based drug maker has about 30-odd plants across the country, a company official said.

Cipla is also looking to raise $100 million in foreign currency loan to off-set the impact of the strong rupee, he added.

The company would take a Rs 200-crore hit on exports of about Rs 2,000 crore because of the appreciating rupee, according to him.

The Rs 3,500-crore company projects 10-12 per cent growth in the current fiscal, though profits could be lower when compared to the previous year, he indicated.

The official admitted that the company was “viewing with interest” niche business segments for acquisitions, not merely to increase sales but to enhance value by entering new business segments like bio-technology, for instance.

The company has, in the current year, received Rs 48 crore for technical knowhow that it has shared with companies and the payment has come on completion of milestones.

However, the official denied any tie-up with GlaxoSmithKline on inhalers.

Cipla has eight HFA inhalers, of which two have got approval in the European Union and details of the rest have been submitted, he said.

CFC-free inhalers from Cipla have got approval in Denmark and Portugal and approvals are expected in the UK and Spain this year.

Responding to queries whether Cipla and Reliance were in acquisition-related talks, Dr Hamied told Business Line : “The answer is No. I have not met anyone, I have not talked to anyone.”

Earlier, he told shareholders that there was no sourcing tie-up with Reliance for the retail sale of medicines.

NEW DELHI: Domestic major Cipla has sent a legal notice to the AIDS Healthcare Foundation, the US-based NGO which has alleged that the Indian company is selling its anti-AIDS drug, Viraday, in India at two and half times the price it sells in Africa.

Cipla joint MD Amar Lulla told ET, “We do not sell Viraday tablets in Africa. We have send a legal notice to the NGO asking them to apologise with an advertisement for their false allegations.” He claimed that the NGO has apologised, but the company wants the clarification to be issued at a public forum. Cipla is one of the largest exporters of antiretroviral drugs worldwide and its drugs are sold in 60 countries.

However, the NGO refuted the company's claim and continues to stand its ground. AIDS Healthcare Foundation's Asia Pacific bureau chief Dr Chingkholal Thangsing said: “We have no reason to apologise. There has been some technical (grammar) error in the advertisement. We will withdraw that technical aspect but continue with our campaign.”

He added that Cipla has “offered to sell the drug at Rs 21,000 per year to Medical Sans Frontier (MSF)” which means that the company is willing to sell the drug at that price. In India, the drug is sold at Rs 54,000, thus restricting access to many AIDS patients, he claimed.

Though the company had indeed offered to sell the drug to MSF at the Rs 21,000 price, it was never sold and the offer has already been withdrawn, Mr Lulla added. The NGO has replied to Cipla's earlier notice after the NGO went public with its allegation earlier this month. However, the NGO is yet to reply to the legal notice from Cipla which has asked it to apologise for its allegations.

On August 9, the NGO had alleged that Cipla's drug, Viraday tablets, is available to a patient in Africa for Rs 21,200 for a year's treatment while it costs Rs 54,000 in India. The NGO had issued advertisement in leading Indian newspapers with the same allegations. Viraday tablet is Cipla's generic three-in-one combination antiretroviral therapy that AIDS patients have to take just once a day.

The Monopolies and Restrictive Trade Practices Commission (MRTPC) is expected to probe the NGO's allegation.
Meanwhile, it is learnt that some global organisations have also shown interest in these developments. UNAIDS and World Health Organisation (WHO) have sought details of the allegation from Aids Healthcare Foundation.

Mumbai, Aug 20
The “morning after pill” used in emergency contraception will now be available in India from the Mumbai-based Cipla under the brandname I-pill. Cipla is looking to generate awareness on this product to promote better spacing of children while planning a family, besides safeguarding against unintended pregnancies.

OTC product

Priced at Rs 75 for a tablet, this single pill emergency contraception (EC) will be sold over the counter, offering greater convenience and stronger dosage when compared to other products in the market, said Dr Jaideep Gogtay, Cipla's Medical Director. I-pill is the generic version of levonorgesprel, sold globally as Levonelle One step by Schering AG.

Currently, EC pills in the market are half the dosage i.e. 0.75 mg and two tablets need to be taken. The convenience with I-pill is that the single pill has double the dosage and when taken within 72 hours of unprotected sex or contraceptive failure, it decreases chances of pregnancy by 90 per cent, he said.

Side effects

Side-effects associated with other EC medicines, such as nausea, will be seen with this medicine too, he said. Addressing concerns of misue, he indicated that the medicine was allowed to be an OTC product because it had no serious side-effects. But to encourage responsibility in the use of the medicine, the company has started a toll-free helpline (1800-22-9898) and Web site to share information on the product.

Reproductive health and gynaecology products have been part of Cipla's basket of products, but I-pill is being supported by a national advertising campaign to create greater awareness on the availability of such drugs, he said.

Mumbai, Aug 19
Mumbai-based pharmaceuticals major Cipla Ltd is in talks with Government Pharmaceuticals Organisation (GPO), a Thailand government owned company, for supplying raw materials for manufacturing HIV/AIDS drugs in Thailand. Early this year, the Thai government has issued compulsory licenses to manufacture various life saving drugs patented by multinational pharmaceutical companies in Thailand.

Instead of providing the compulsory licenses to any other companies, the Thai government is learnt to have decided to manufacture the drugs at its own company, GPO. For manufacturing the drugs, GPO, established under the ministry of public health, is all set to purchase raw materials at lower prices and is also in initials level of talks with Cipla. Earlier, there were reports that Cipla was to supply the Aids drug, Lopimune (lopinavir + ritonavir), a generic version of Kaletra, marketed by US major Abbott to Thailand government. Sighting overpricing reasons, Thai government has issued compulsory licenses to manufacture drugs including Aids drugs like Kaletra and Efavirenz and cardiac drug, Plavix. Lopimune is available at 40-50% lower than the innovative drug, Kaletra.

Acknowledging the development, Amar Lulla, managing director, Cipla, told FE, “We are in talks with GPO for entering into a supply deal with them and the talks are at a hopeful stage. Once the deal is signed, we will supply raw materials for all the drugs for which compulsory license has been invoked and also for other Aids drugs.” However, he refused to divulge any more details.

In Thailand, about more than 1 lakh out of 5 lakh people living with HIV/Aids depend on GPO-VIR, the cheaper version of the first-line anti-retroviral (ARV) therapy produced by the GPO. An estimated 25,000 HIV-positive people have developed a resistance to the drug, and need the combination drugs of lopinavir and ritonavir.

According to WHO reports, Cipla is the second company which obtained the largest number of registrations for ARV drugs. The company has the largest number of WHO pre-qualified drugs. Cipla is the largest supplier of Aids drugs to Global Fund to Fight AIDS, TB and malaria, for its free treatment programme.

Mumbai, Aug. 9 Not one pack of AIDS drug Viraday has been sold by Cipla in Africa till date, the company has said, refuting charges of over-pricing made by AIDS Healthcare Foundation (AHF).

The AHF had in newspaper advertisements on Thursday alleged that Cipla was charging more for its AIDS drugs in India, as compared to the price they sell it in Africa. This keeps the medicine inaccessible to many in India, said AHF, a US-based non-profit organisation.

The advertisements in leading newspapers cited the specific instance of Viraday. The AHF claimed that Cipla sold the drug at Rs 54,000 per patient per year in India, as compared to Rs 21,200 per patient per year in Africa.

‘Ad defamatory'

Cipla's Chief Executive Officer, Mr Amar Lulla, told Business Line that Cipla had not sold a single pack of Viraday in Africa. “We are consulting our legal experts,” he said.

Cipla sells other AIDS drugs (not Viraday) to the National Aids Control Organisation in India at the same prices as in Africa, he said.

The full-page advertisements cost lakhs of rupees, he said, and added, “Why don't they use this money to help AIDS patients?”

The US FDA has approved the first fixed-dose, triple combination HIV/AIDS drug for children under the President's Emergency Program for AIDS Relief (PEPFAR).

The FDA on August 13th announced the tentative approval of India-based Cipla's fixed-dose tablet combining lamivudine (GlaxoSmithKline's Epivir), stavudine (Bristol-Myers Squibb's Zerit) and nevirapine (Boehringer Ingelheim's Viramune).

The agency's antiviral products division director, Dr Debra Birnkrant, called the three-drug fixed regimen an extremely important and novel product. The tablet can be swallowed or dissolved in water. It does not require refrigeration and can be dosed in patients weighing as little as 5kg. It is the first fixed-dose anti-HIV product approved for children under the age of 12 years.

The FDA's review of the product took approximately eight months and was complicated by the fact that it involved three different drugs and a novel formulation, Dr Birnkrant said.

The agency also granted tentative approval under PEPFAR for nevirapine tablets manufactured by Hetero Pharmaceuticals of India. The two approvals mark the 50th and 51st under the PEPFAR programme.

NEW DELHI: Cipla has edged past Ranbaxy Laboratories to become the No. 1 company in the domestic pharma retail market. It pipped Ranbaxy for the 12-month period ended May 2007 while Ranbaxy was the market leader in terms of domestic marketshare for the 12 months ended in March and April.

According to ORG figures, for the year ended May 2007, Cipla is the market leader with 5.05% marketshare closely followed by Ranbaxy Laboratories at 5.04%. Glaxo SmithKline (GSK) is at the third position with 5%. For the month of May alone, Cipla's marketshare was 5.05% against Ranbaxy Laboratories 4.82%. Incidentally, on a monthly basis, Cipla has been the market leader for the last three months.

Cipla, Ranbaxy and GSK have been the top contenders for the top slot for some years now. Ranbaxy has been the dominant player, leading the market since July last year.

GSK briefly took the top position earlier this year but Ranbaxy regained the No.1 position in March for the 12-month period, only to be replaced by Cipla in May.

Cipla, however, downplayed its new position. “The ORG figures are taken from a small sample and give a broad indication of the industry trend, ” company joint MD Amar Lulla told ET.

ORG figures are based on the sales data of around 15,00 chemist stores across the country. When contacted, a Ranbaxy Laboratories spokesperson said, “We are confident of being No 1.”

In terms of revenue, the marginal difference of 0.1% in market share means that Cipla's revenue from domestic market is about Rs 2 crore more than Ranbaxy Laboratories in retail sales. The market share ranking is, however, different from the revenue ranking of pharma companies. That's because overseas revenue constitutes a large portion of the overall revenue of the big pharma companies. In revenue terms, Dr Reddy's Laboratories is the largest pharma company followed by Ranbaxy.

While Cipla, Ranbaxy and GSK have been jokeying for the top position in the domestic retail market for the past few years, a domestic acquisition by any one of them would give that company an unassailable lead. Ranbaxy has been eyeing an acquisition in the domestic market for a while now.

ORG figures do not include the Rs 7,000 crore hospital sales, and therefore the market share in retail sales may differ from the overall market share.

According to ORG figures, Mankind Pharma is the fastest growing pharma company in the top 50. As a matter of fact, while the market shares of majors such as Cipla, Ranbaxy Laboratories and GSK have either remained stable or have marginally gone down from around 5% over the past few years, small and mid size pharma companies have made a significant presence in the market. Mankind with 2% market share (ranked 15%) and Elder and Emcure Pharma with one percent each have made it to the top 30.

Cipla has developed and launched an estradiol transdermal spray (marketed as EstaSpray) for menopausal women in India. EstaSpray, which Cipla claims is the world's first such estradiol spray, offers patients safe and effective oestrogen replacement therapy (ERT).
EstaSpray is a small, hand-held spray device that delivers a preset dose of a formulation of estradiol through the skin. Dr Duru Shah, senior gynaecologist and president of the Indian Menopause Society said that ERT given in the smallest possible dose for the shortest possible time can significantly relieve acute vasomotor symptoms in postmenopausal women. The spray formulation offers considerable advantages over oral and other transdermal preparations, Dr Shah said.
Cipla's CEO, Amar Lulla, said that the company has sought a patent for the platform technology for EstaSpray and also expects to export the product. "We are getting the product registered and expect to export it to markets in South America, the Middle East and Africa," Mr Lulla told Scrip. The product has been priced at about Rs1,800 ($44) for 180 doses.

Significantly, Cipla's announcement comes even as Vivus, which has been developing EvaMist (estradiol), an investigational metered-dose transdermal spray for the treatment of the vasomotor symptoms associated with menopause, recently transferred the rights to EvaMist to KV Pharmaceutical in exchange for a $10 million closing payment. KV, which expects EvaMist to get US FDA approval in the second half of the fiscal year ending March 31st 2008, will pay Vivus about $140 million thereafter. EvaMist, which reduced the frequency and severity of hot flushes over placebo in a Phase III clinical trial, is estimated to have a peak market of about $125 million.

India's leading generic pharmaceutical company, Cipla, has always done things differently. Well-known for its cut-price human pharmaceutical generics, Cipla has often been a thorn in the side of many an international competitor, churning out indigenously-developed new products at a fast pace both for the domestic and international markets. The company has also, in general, kept away from major acquisitions, preferring organic growth and the alliance route to enter many big international markets. Among other advantages, alliances help share the costs and risks that come with expanding into new markets. Cipla has used an unconventional route to develop its animal health business as well, tapping the international market first and then looking homewards. The company has been focusing on developing its veterinary export business ahead of moving full-throttle into the domestic market with its entire range of animal health products. Out-licensing is another developing plank of its international business growth plan. Cipla's CEO, Amar Lulla, said that exports account for more than 90% of the company's animal health business and the business has performed "as per the targets" set both in the international and domestic markets in 2006. Cipla's animal health business is estimated at about $14 million for 2006-07, despite the resurgence of avian influenza, which adversely affect sales of some poultry products in Asia and parts of Africa. The company exports its animal health products to more than 91 countries, with Africa, Asia and Latin America representing its major markets. "Cipla has already started exporting its products to markets in the EU and will shortly do so in the US as well," Mr Lulla told Animal Pharm. "We expect to start US exports in the second quarter of 2007. The products are in alliance with partners in the US." The products that will be exported to the US cater to the companion animal segment. Cipla's products are already available in about 12 markets in the EU, and the company expects to expand into the remaining EU markets soon. It has, however, declined to divulge product details due to contractual arrangements. Out-licensing Significantly, the company is also working on out-licensing arrangements for a number of projects. Cipla said that it has developed a range of animal health products according to the requirements of the US Food and Drug Administration's Center for Veterinary Medicine, and entered into marketing arrangements with customers for these. "The customer will be responsible for the registration process and we will supply all the necessary documentation required," the company explained. Some of the products, for which discussions are in an advanced stage, include detomidine injection, medetomidine injection, atipamezole injection, omeprazole paste, co-amoxiclav formulations, meloxicam oral suspension and injections, fipronil preparations, several dewormers for companion and equine animals. Cipla is also keen to develop in-licensing arrangements not just for the Indian market, but also in various other parts of the world. The company is expanding its product offerings abroad and is working on a program to launch aquaculture products internationally in export markets. "This is likely to happen by the end of this year," Mr Lulla said. Business instinct Cipla attributes some of the growth momentum in its fledgling veterinary business to "business instinct", but adds that the market opportunities for exports have also been compelling factors. "The process of the servicing the needs of the animal health industry started in 2002. We ventured in to the veterinary business to fulfill certain product requirement requests of our international customers of human pharmaceuticals, who also had animal health businesses. We developed and made some basic products for them like antibiotic and anthelmentic powder injections and liquid preparations," the company said rather candidly. Gradually the company brought in more international customers and partners, developing new products along the way. Since the growth of the veterinary business was fuelled by its new international partners and alliances, the company simply stayed on the exports course. "In a way, looking first at international markets helped us to understand this business better," Cipla said. "Besides, the international market was larger, more developed and remunerative compared with the Indian market. And the domestic market was unstructured, with product quality expectations of customers figuring at the lower end," the company explained. The animal health industry in India has been estimated at around Rs8bn for 2005-06, with the dairy and poultry segments dominating the market in terms of volume and value. The companion, equine and swine segments account for about 10% of the Indian market, according to some industry experts. There is, however, no formal audited market research data on the Indian animal health sector. Domestic business Cipla's domestic focus is mainly on the equine and companion animal products segment, where it expects to develop a strong presence. "Equine products have been extremely well received in the Indian market and the leading products are in the deworming and antiulcerant segments," the company said. In the companion animal segment, the products are mainly in areas such as ear infections, antibiotics and non-steroid anti-inflammatories. The equine and companion animal businesses have been the fastest growing segments for Cipla over the past, largely due to the wide range of products, including niche products, which offers customers a "one-stop shop" for veterinary medicines. For example in the equine segment, the company complements its range of dewormers with niche products for ulcer treatment and respiratory disorders. Similarly, in the companion animals segment the company offers dewormers, general antibiotics and a range of ear treatments, as well as somewhat more sophisticated products such as cyclosporin eye ointments and capsules, and flea and tick treatment products. The companion animal segment has emerged as one of the fastest growing segments in the Indian industry, growing at an estimated 19% per year. Some experts say that India's buoyant economy, which has led to higher disposable incomes and a growing awareness about pet health issues, has impacted growth in this segment. Cipla also has a range of herbal products in the equine and companion animal segments and there are plans to target the poultry and livestock segments as well. The leading products in this segment include Tefrosol Forte Liquid for liver protection and Dermavet Ointment for wounds and cuts for horses and companion animals. Earlier the company also said that it expects to launch a range of generic products including meloxicam chewable tablets, florfenicol injection and toltrazuril 5% on certain export markets and then gradually introduce these on the domestic market. Some of the products that have already been launched include Care-O-Pet (carprofen tablets), Buprocip Injection (buparvaquone) and Heartcare chewable tablets (chocolate-flavored tablets containing ivermectin and pyrantel). Clearly, Cipla's differentiated growth plans in the animal health segment hold promise given that the company has yet to tap into the Indian market fully and that new business plans are poised to take off. This may just be the one area where the company hopes its performance is no different from that of its human pharmaceutical business, which has consistently outperformed the market over the years.

Cipla has launched Virenza inhalation capsules (zanamivir), a generic version of GlaxoSmithKline's Relenza, in India for the treatment of influenza and avian flu caused by the H5N1 virus. Cipla says it is the first company to launch a generic version of the product. It will be available for inhalation using a novel, dry-powder inhaler, the Revolizer, the company added. Cipla's CEO, Amar Lulla, told Scrip that the product will be available at discount of about 40% to Relenza's US price. The company will also export the product to markets that are not patent-protected, he added. Last year GlaxoSmithKline entered into an agreement with the US government to provide states with Relenza as they prepare for a potential influenza pandemic. The Department of Health and Human Services had, at that time, guaranteed the initial purchase of $16.8 million worth of Relenza (Scrip No 3178, p 19). Cipla has been at the forefront of launching cut-price generic products across therapeutic segments. Last year, it launched oseltamivir (marketed as Antiflu), a generic version of Gilead Sciences/Roche's Tamiflu. The domestic launch of generic zanamivir is expected to be less controversial as Relenza does not qualify for patent protection in India, since it was patented prior to 1995 - the cut off date to qualify for patent protection in India. Since 2003, avian flu outbreaks have been reported in nearly 50 countries, particularly in the Asia Pacific region. The WHO has confirmed that 12 countries have reported 288 human cases, of which 170 have reportedly been fatal.

Mr. Amar Lulla receiving the award at the International Trade Awards 2006 DHL and CNBC-TV18 announced the first ever International Trade Awards 2006. The awards aim at recognizing corporates with the most outstanding and consistent business and financial performance in its international trade category. The awards are targeted at exporters-manufacturers, service providers, international trade houses as well as importers who create value and export content.

Country’s second-biggest drug maker Cipla, which slashed prices of generic AIDS drugs internationally, is soon to champion another global move to contain malaria. The company has entered into a development and supply agreement with Drugs for Neglected Diseases Initiative (DNDi), a global non-profit organisation, for a new anti-malarial combination drug. The drug, a new fixed dose combination of artesunate and mefloquine, will be manufactured by Cipla using the technology developed by DNDi. “The agreement is for development and commercialisation of a new fixed dose combination of artesunate and mefloquine (AS+MQ) indicated for the treatment of uncomplicated Falciparum malaria. The product technology is coming from DNDi. Cipla will manufacture and make the product available in southeast Asia and other parts of the world at affordable pre-agreed prices,” Amar Lulla, joint managing director, Cipla, said. He declined to comment on the details of the agreement and the volume of business that is expected. The drug to be launched by Cipla has come out of a DNDi initiative called “FACT Project” established in 2002. Global agencies such as WHO, UNICEF, UNDP, World Bank, and Health NGO Medicines Sans Frontiers are part of the DNDi initiative. Pharmaceutical companies Sanofi Aventis and Farmanguinhos are also part of the initiative.