The announcement of the new biosimilars guidelines, "Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India", by the Indian government is a welcome move but India's biotechnology industry believes more needs to be done to streamline the existing regulatory framework for biologics and vaccines. In the last few years, India has seen a robust growth in its biosimilars portfolio. The growing biosimilars market offers huge potential for companies involved in research and development and manufacturing.

Biosimilars can also go a long way in meeting India's need for affordable healthcare for its huge 1.2 billion population. Prime Minister Dr Manmohan Singh, in his 66^th Independence Day speech, said the government was working on a new scheme for distribution of free medicines in the country through public hospitals and health centres. The National Health Scheme will be launched in a couple of years by combining the National Rural Health Mission and the National Urban Health Mission to be started soon.

There are about 100 biopharmaceutical companies actively involved in research and development, manufacturing and marketing of biologics in India and the country has witnessed drastic increase in the number of branded biosimilars in the last few years. In 2005, 14 therapeutic drugs were available in 50 brands. The number has increased to 20 therapeutic drugs in 250 brands in 2011. There are 10 companies offering about 40 brands of insulin products. Among the other leading therapeutic products, Erthropoietin is available in with 55 brands, chorionic gonadotropin is available in 48 brands, streptokinase has 33 brands, and both interferon and heparins are sold under 10 brands each.

Currently, 20 recombinant therapeutics are approved by the Genetic Engineering Approval Committee (GEAC) for marketing in India. The GEAC is an apex body under the Ministry of Environment and Forests. Since 2005, the review committee on genetic manipulation (RCGM) of the GEAC has recommended 91 clinical trials to be conducted in India related to recombinant pharmaceutical or therapeutic products with the permission of Drug Controller General of India (DCGI).

The draft guidelines were announced in June this year by Department of Biotechnology Secretary Dr M K Bhan at Boston BIO. The department had step up a 20-member committee in association with Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare comprising industry experts, scientists and government officials to draft the guidelines. The committee headed by Dr G N Singh, Drugs Controller General (lndia) and Dr V P Kamboj, chairman, RCGM and former director of Central Drug Research of Institute, submitted the draft guidelines to the government in March for final consultations of the industry.

"The guidelines on similar biologics released by the Government of India will provide a tremendous boost to Indian biopharmaceutical players. With a potentially huge domestic market and growing global opportunities, India is poised to become a major player in biosimilars," says Mr William Lee, head of Regulatory Strategy, Quintiles Asia. Quintiles is the first global clinical research organization to set up operation in India in 1997.