NextBillion - An Initiative of the William Davidson Institute at the University of Michigan

Monday, March 9, 2015

Compared with many other industries in the country, save for the software industry, the Indian pharmaceutical sector’s performance has been impressive and its future secure.

The major reasons that stand out are the adeptness of the early domestic pharma firms to take the path of self-learning, their determination to succeed against all odds, and the supportive provisions of the Patent Act, 1970, which allowed process patents instead of the product patents.

India’s domestic companies took the path of developing new drug making processes instead of drug discovery, and they focused on establishing production facilities and securing approvals from the Food and Drug Administration (FDA), while following current good manufacturing practices (cGMP) and adopting standard operating procedures (SOP).

While Indian drug companies have moved beyond making generic drugs and active pharmaceutical ingredients (APIs), and have strengthened their position in contract manufacturing, research and clinical testing, their forte remains generic drugs. India accounts for almost 20 per cent of the world’s generic drugs.

For many people in India and around the world, patented medicines are often beyond their means and generics are their only hope. With a number of drugs going go off-patent soon, the stage is set for India’s pharmaceutical industry to further consolidate and expand its position in the growing generic market.

Drugs worth $100 b go off-patent

According to the IMS Institute for Healthcare Informatics’ report, ‘The Global Use of Medicines: Outlook Through 2016’, while branded drugs Nexium, Cymbalta, Celebrex, Symbicort, Lunesta, Restasis, Evista, Sandostatin LAR, and Actonel went off-patent in 2014, the drugs listed to go off-patent in 2015 include Abilify, Copaxone, Namenda, Provigil, Combivent, Zyvox, Prezista, and Avodart, besides Gleevec. Year 2016 will witness the expiry of patents relating to four blockbuster drugs only — Crestor, Benicar, Benicar HCT, and Cubicin.