The deaths of 11 children in Jammu’s Udhampur district should drive home the dire urgency of plugging loopholes in the country’s drug regulatory regime. Initial investigations point to a cough syrup, Cold Best-PC. A laboratory in PGIMER Chandigarh has found the presence of the toxic compound, Diethylene Glycol, in samples from a batch of the medicine manufactured by the Himachal Pradesh-based Digital Vision. The state’s drug regulator has suspended the company’s manufacturing licence. But Digital Vision’s track record — in the last five years, drugs manufactured by it have been red-flagged more than once by the country’s apex drug regulatory authority, the Central Drug Standard Control Organisation (CDSCO), as well as by regulators in Gujarat, Karnataka, Maharashtra and J&K — should have been reason enough for regulators to be more vigilant about the company’s production practices.
Under the Drugs and Cosmetics Act, 1940, regulating the manufacture, sale and distribution of drugs is primarily the concern of state authorities. The CDSCO is responsible for laying down the standards of drugs, coordinating the activities of state regulatory authorities and providing them expert advice. But by all accounts, there is scarcely any information-sharing between the Centre and the states and among states. The CDSCO has not issued binding guidelines to state regulators for recalling medicines that are not of standard quality (NSQ). A batch of drugs that is deemed NSQ in one state could find its way to the market in another. Himachal’s drug control authority has seized or recalled at least 1,500 bottles of Cold Best-PC. But by the agency’s own admission, more than 3,000 bottles of the batch of cough syrup deemed substandard by PGIMER made its way to the market.
For more than 30 years, India has been the largest supplier of generic medicines in the world. However, the country’s pharma industry has never answered satisfactorily the questions that have been asked about the quality of its products. In 2015, the EU banned 700 drugs produced in the country. Last year, Indian drug manufacturers received at least 20 letters of warning from the US FDA over the quality of their products. Last year, the Bureau of Pharma PSUs of India, which implements the Pradhan Mantri Janaushadhi Pariyojana, found 25 batches of drugs supplied to the Centre’s flagship affordable medicine programme to be substandard. Drugs of questionable quality prolong illness, cause antibiotic resistance, and, as in the case of Cold Best-PC, even death.
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