“(In the) earlier days, there were no regulations (in India). And regulations were only on paper,” said Indian Pharmaceutical Alliance secretary-general Sudarshan Jain. “Now we’ve got Schedule M, which is very close to the global market (standards).”
To improve standards and expand India’s pharma industry, the Modi government revised Schedule M, a set of rules under the Drugs and Cosmetics Act, last December.
Drug manufacturers currently have until the year end to align their quality controls more closely with the WHO’s Good Manufacturing Practices (GMP) for pharma products. Doing so would allow more small and medium Indian firms to enter the export market.
And with a possible decoupling between the US and China’s biotech industries, the South Asian country could gain a greater foothold in the global pharma space.
But with little time left to clean up their act, many small and medium local firms are seeking a two-year extension of the deadline. With its eye on increasing exports, can India cure its pharma ills, the programme Insight asks.
WATCH: Bad medicine — Why India is racing to improve pharma standards amid US-China trade rivalry (46:58)
