Pharmaceutical and Food Standards In India

Central Drugs Standard Control
Organization
Dte.GHS, Ministry of Health and Family Welfare, Government of India

Click anywhere in the above caption/title to visit the organization in India which governs the standards of manufacture for medical drugs in India.

India now surpasses any other country in the world for the production of medical drugs used, not only in India, but much more commonly, all over the world, including the US.

People who think some medical drug is from a US Company and "probably" made somewhere in the US would be surprised at the truth of the matter. Most of the medical drugs sold in the US are manufactured outside the US and much of that volume of product sales comes from manufacturers in India.

Central Drugs Standard Control Organization

Directorate General of Health Services

Ministry of Health and Family Welfare

Government of India

Nirman Bhavan, New Delhi -110011

Phone: 91-11-23061806

Fax: 91-11-23062648

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$30M Gates Foundation Grant Aims To Greatly Reduce Visceral Leishmaniasis (Black Fever) Deaths, Institute For OneWorld Health

Main Category:
Article Date: 05 Dec 2005 - 9:00am (PDT)

The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the U.S., today announced that it has received a US$30 million grant from the Bill & Melinda Gates Foundation to initiate and evaluate the impact of a pilot program to dramatically reduce morbidity and mortality from visceral leishmaniasis (VL) in the rural communities of India, Bangladesh, and Nepal.

VL, also known as kala azar (“black fever”), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs. VL is endemic in 62 countries, and the number of new VL cases per year is estimated at 500,000. With the exception of malaria, VL kills more people than any other parasitic disease. OneWorld Health completed phase III clinical testing last year with paromomycin, an off-patent antibiotic, for the treatment of VL in India. This large-scale clinical trial in Bihar, India, demonstrated that paromomycin is both safe and effective. OneWorld Health is submitting an application for drug approval to the Indian regulatory agency in early 2006.

“The elements for a sustainable public health solution for VL in India, created and managed by Indians, are coming closer together,” stated Victoria Hale, PhD, founder and CEO of OneWorld Health. “Our role is to fortify the arsenal of public health tools. The Gates Foundation funds are the catalyst for us to partner with some remarkable researchers, government officials and manufacturers in India, and other nations in the future, to create a local solution that meets the highest international quality standards. We are energized about the prospect of controlling a deadly disease in India and beyond.”

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“The development of this new drug is a terrific global health success story. By developing a low-cost, off-patent drug for a neglected disease, OneWorld Health and its partners have given the world a more effective cure with a good safety profile, at a fraction of the cost,” stated Bill Gates, co-founder of the Gates Foundation. “I am also very pleased that the Indian government has been a key partner in this effort, and has committed to eliminating the threat of visceral leishmaniasis for all Indians.”

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The main activities of the grant, which is designed to lay the foundation for a long-term VL control program, include:

· Phase 4 demonstration study: To construct an effective and sustainable delivery strategy, OneWorld Health will formalize partnerships with local government, primary healthcare centers and nongovernmental organizations (NGOs). The partners will conduct a study to demonstrate the feasibility of administering paromomycin in rural field conditions, and to provide further data on the safety and efficacy of the drug.

· Clinical trial in children: To extend the benefits of this safe drug to a larger population, a new clinical trial will include children under five years of age.

· U.S. FDA or EMEA approval: Although OneWorld Health will seek regulatory approval in India first, it also plans a regulatory submission to the FDA or the European Agency for the Evaluation of Medicinal Products (EMEA). In 2005, the FDA and the EMEA each granted orphan drug status to OneWorld Health for paromomycin for the treatment of VL.

· Local drug manufacture to GMP standards: OneWorld Health will ensure that paromomycin is manufactured in India using FDA Good Manufacturing Practices, the highest international standards, at an affordable price, and will also ensure scalability for subsequent countrywide distribution.

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To secure high quality, affordable local manufacturing, OneWorld Health has partnered with IDA Solutions, part of the International Dispensary Association (Amsterdam, Netherlands), the world's leading not-for-profit supplier of drugs to developing countries. IDA Solutions has contracted with Gland Pharma Ltd., a U.S. FDA-approved pharmaceutical company specializing in injectable drugs based in Hyderabad, India. Gland has agreed to manufacture paromomycin and make it available at a fraction of the cost of other VL drugs, which range in price from several hundred to thousands of dollars per cure. IDA Solutions and Gland have agreed to restrict sales of paromomycin to the government sector only, reducing the risk of drug resistance resulting from improper use of the drug.

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At the World Health Assembly in May 2005, the governments of India, Bangladesh, and Nepal committed to eliminate VL in their countries. Paromomycin may provide a critical tool to help these countries achieve their goal.

About The Institute for OneWorld Health

The Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company, develops safe, effective, affordable new medicines for people with diseases of the developing world, including visceral leishmaniasis, malaria, diarrhea and Chagas disease. OneWorld Health applies its entrepreneurial business model with a staff of experienced pharmaceutical scientists that identifies promising leads and drives development from pre-clinical studies to clinical trials through regulatory approval. The Institute for OneWorld Health, headquartered in San Francisco, Calif., is a tax-exempt 501(c) (3) U.S. corporation (oneworldhealth.org). Media resources are available at oneworldhealth.org/media/index.php.

Joanne Hasegawa
Associate Director of Communications
Institute for OneWorld Health
A nonprofit pharmaceutical company. Fulfilling the promise of medicine.
50 California St., Ste. 500
San Francisco, CA 94111
415-421-4700 ext. 322 Phone
415-421-4747 Fax
jhasegawa@oneworldhealth.org
www.oneworldhealth.org

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INDIA, WORLD CLASS

Wednesday, October 26, 2005 08:00 IST
P A Francis

No third world country other than India has the distinction of having a world class pharmaceutical industry today. China and Brazil are probably two other countries which are very close to India's size and quality levels. But the kind of international presence and the level of sophistication in manufacturing and research, the Indian pharmaceutical industry achieved so far, both China and Brazil cannot match.

Two main factors are responsible for attaining this kind of excellence by the Indian pharmaceutical industry.

First, an urge to adopt better manufacturing standards amongst pharmaceutical entrepreneurs in India.

Secondly, constant drive of the industry to enter the international market.

In the eighties, India established itself as a leading exporter of quality APIs and intermediates to the world pharmaceutical industry confined largely to the US and Europe. Dr Reddy's and Ranbaxy have thus earned the reputation of reliable Indian suppliers of the drug raw materials to the international companies. They were followed by a large number of medium and small players in the subsequent years. With the exposure to international market, the leading Indian companies had also started upgrading their manufacturing facilities.

Gradually getting approval of manufacturing facilities by international regulatory agencies like US FDA,UK MHRA,TGA, etc has become a routine amongst all pharmaceutical exporters.

India can thus claim to have the largest number of US FDA approved manufacturing facilities outside the US.

And that has prompted Indian companies to shift from API manufacturing to more profitable and a fast growing segment, generics. Currently a dozen top Indian companies are major suppliers to the US and European market. This is no small achievement for a developing country like India. To maintain this trend and grow further from this stage, it is important for the Indian industry to look at the next stage of growth.

That is what leaders of Indian pharma industry has been doing during the last two years: acquiring companies and building alliances mainly in the developed world.

During the last two years, Indian pharma industry invested almost Rs 2000 crore for acquiring and building tie-ups in the US and Europe. Corporates like Ranbaxy, Dr Reddy’s, Wockhardt, Sun Pharma, Lupin, Torrent, Zydus Cadilla, Glenmark, Shasun and Matrix are already having direct presence in Americas and Europe either by buying companies or by acquiring stakes.

Now a number of medium sized Indian companies are also aspiring to set up bases in the US. The main objective of most of the Indian companies is to capture a sizable share of global generics market estimated at US $ 52 billion. This may not be a tough task for the Indian pharma companies considering its current potential. But the great challenge before the Indian pharma industry is how to make a dent into branded market of the developed world.

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India Volumes - 4th in the global marketplace

Thursday, October 23, 2003 08:00 IST
Our Bureau, Mumbai

The Indian pharmaceutical industry has achieved a compounded annual growth rate (CAGR) of 17 per cent since 1996 to reach a total turnover of Rs. 23127 billion in FY2001. The industry has over 20,000 units reportedly engaged in the manufacture of pharmaceutical products.

According to the estimates of the Organisation of Pharmaceutical Producers of India (OPPI), 289 firms in the organised sector 28 account for around 60 per cent of the total output of the industry. Further, around 1,500 companies in the small scale and tiny sectors are engaged in the formulations business, according to the OPPI estimates. The total investment in fixed assets in the Indian pharmaceutical industry at the end of FY2001 stood at Rs. 29 billion.

The Indian pharmaceutical industry is one of the largest among developing countries. It contributes 8 per cent in volume terms but only 1per cent in value terms to global pharmaceutical sales (figures as of calendar 2000). Thus, the Indian pharmaceutical industry ranks 4th in terms of volume but 13th in terms of value globally. India's small share in value terms is attributable to the relatively lower prices of drugs in the country.

The size of the domestic market for formulations was estimated at Rs. 154 billion in calendar 2001. The overall production by the domestic pharmaceutical industry in FY2001 stood at Rs. 228 billion, of which formulations accounted for 80 per cent and bulk drugs for the balance 20 per cent. Of the total market, the share of Indian companies has increased from around 20 per cent in 1970 to 70 per cent now. Pharmaceutical companies in India manufacture bulk drugs in several important therapeutic categories and the industry has facilities to make all dosage forms, namely, capsules, injectables, tablets, oral, and liquids. There are over 20,800 brands in over 200 therapeutic segments available in India.

Anti-infectives comprise the largest therapeutic segment in India, accounting for about 26 per cent of the market. The size of the therapeutic segments differs across regions because of variations in the income level, demographics, hygiene levels and sanitation, health infrastructure, disease patterns and differences in lifestyles.

Production and Trade

The domestic pharmaceutical industry meets about 90 per cent of the country's total bulk drugs requirement and almost the entire demand for formulations. There are over 20,000 players in the industry, with a large number of them involved in the production of unbranded products. Most of the small-scale units are formulators. In proportionate terms, production, of bulk drugs by the organized sector has declined overtime, which is an outcome of the consistent decline in margins in the bulk drugs business.

The new generation bulk drugs business is still controlled by the organised sector. This sector is also involved in the export of bulk drugs to markets both in the developed and developing countries. Moreover, in the formulations segment, the organised sector dominates the market. Because of the high and consistent margins, pharmaceutical companies are shifting their focus to formulations for both domestic sales and exports.

India is almost self-sufficient in the production of drugs and formulations as far as domestic demand is concerned. Besides, it exports to different regions/countries, including Europe and North America. Overall, exports of pharmaceutical products by Indian companies increased at the rate of around 27 per cent during the period FY1991-2001. This is considerably higher than the CAGR of 17.5 per cent in overall production by the industry during this period. The cost competitive edge of Indian producers has helped them access international markets.

Growth Rate

The size of the Indian pharmaceutical industry was estimated at Rs. 231 billion (sum of formulation production and bulk drug exports, both at factory price) in FY2001. Overall, the industry reported a growth rate of 17 per cent during FY1996-2001.

The Indian pharmaceutical industry recorded a growth rate of 17 per cent in FY2001 although the domestic market for formulations witnessed a growth of around 11.4 per cent. In recent years, with the increase in income level, improvement in hygiene and sanitation conditions, and better availability of healthcare infrastructure, the disease pattern in India has changed in favour of lifestyle related diseases.

Thus, drugs in the therapeutic segments related to lifestyle have a considerably high growth, although the turnover is relatively low. Anti-infectives, the largest therapeutic segment in the Indian pharmaceutical industry (26 per cent market share), witnessed a growth rate of 2-3 per cent in FY2001. Within the anti-infectives segment, drugs based on the third and fourth generation cephalosporins witnessed a growth rate of 16-17 per cent. In calendar year 2001, while the domestic pharmaceuticals market reported a growth of 10 per cent over the previous calendar, the cardiovascular (CVS) segment recorded a 10-12per cent growth. Drugs in the anti-diabetes segment witnessed a growth rate of over 35 per cent in FY2001.

Disease Profile

The incidence of disease has a major impact on the growth rate of drugs in specific therapeutic segments. Until the early 1980s, the frequent eruptions of epidemics in India and the increase in the population size had caused a considerable rise in the demand for drugs in the anti-infectives segment.

Source: ICRA

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There is also negative news, generally spread to harm India rather than report the truth. However it is also obvious that the below report was written iun 2002 and the above report written in 2005. It appears that even US news sources have to acknowledge the top quality of Indian drug manufacturing procedures now.

DRUG STORAGE & EFFICACY

Wednesday, January 16, 2002 08:00 IST
P A Francis

Efficacy of pharmaceutical products is largely governed by the principles manufacturing practices followed in pharmaceutical plants. Such standard manufacturing methods, known as GMP is currently followed by hardly 300-odd large and medium scale pharmaceutical units in India today. In other words, the quality and efficacy of drugs produced and sold by 20,000 non-GMP compliant small-scale drug units in the country have to be seriously doubted. With the government decision now to make GMP compulsory under schedule M of the Drugs and Cosmetics Act from December 2003, there is some hope that drug manufacturing standards would be raised to acceptable levels in two years time. Like manufacturing standards, storage and transportation of drugs are other two vital factors that determine the potency of the drug till it is reached the ultimate consumer. Drugs whether they are vaccines, antibiotics or even analgesics have to be stored in prescribed temperature conditions to maintain their potency. The schedule P of the Drugs and Cosmetics Act specifies these temperature conditions for storage of drugs. But these provisions are neither followed by most of the pharma companies nor the trade. Enforcement of these rules by the regulatory authorities is hardly ever done in the country.

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The need for proper storage of drugs starts from the manufacturing units where godowns of pharmaceutical companies are located. Very few pharma companies maintain refrigerated godowns for most of their pharma products. The quality of drugs gets seriously affected during the transportation from the factory to C&F agents and wholesalers through the open trucks. During course of the journey, drugs get exposed to extreme heat conditions particularly during summer. Constant exposure to temperatures above 30 degree centigrade for a few days can substantially degrade the antibiotics and vitamins. Hardly any pharma company insists on transportation of drugs in refrigerated vehicles just to cut costs. The story continues at the retail level too. Of the 5 lakh odd retail chemists in the country, not even 0.5 percent of them have air-conditioned premises. Some of them, located in rural areas, do not even have a working refrigerator to keep essential vaccines and injections safe. By remaining in the shelves of retail chemists for weeks and months with varying high temperatures, the drugs become further degraded. And the consumer pays for these degraded products. It is a matter of serious concern that regulatory authorities have not been looking at such an important issue like this for years. The government's decision now to frame a set of stringent guidelines for post manufacturing quality maintenance of medicines and include them in Drugs & Cosmetics Rules is thus only a long delayed step in the right direction.

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