Indian government upping penalties for pharma manufacturing lapses

The Indian government may be upping the ante for drugmakers that fail to follow new guidelines by doubling the penalties it imposes when manufacturing plants attract the ire of international regulators, according to a report in The Hindustan Times.

The government has drawn up what it calls a "WHO-GMP compliant checklist" for drugmakers and inspectors. GMP refers to good manufacturing practices.

The World Health Organization and other agencies like the U.S. FDA have warned several Indian manufacturers this year that their plants are not compliant and at least 10 plants in the country have faced bans on drugs they make, according to a Reuters report.

G.N. Singh

G.N. Singh, drug controller general of India, said the government has "identified flaws in the drug regulation regime ranging from inadequate drug-testing facilities, lack of databases to a lack of training of regulatory officials," according to the Hindustan Times report. "Any fault with execution will lead to heavy penalties, which are likely to be 50% to 100% more than the current ones," he told the newspaper.

The government has called a meeting of state regulators for Oct. 16 to finalize the plan. The government is also contemplating setting up a system of testing laboratories to assess drug safety.

On the domestic front, in July, India's Central Drugs and Standards Control Organisation (CDSCO) told staff to forget holidays and weekends as it undertakes a massive drug inspection exercise it intends to complete by the end of the year.

The unprecedented plans in India to test at least 42,000 domestic-made drugs to prove their quality was put forth by Singh in May which he said would "tell the world that our drugs are of quality."

At least 44 drug manufacturing facilities are currently barred from exporting to the United States, Reuters reported, severely denting India's reputation as a top supplier of generic drugs and threatening its $15 billion pharmaceutical industry.

The problem is not an isolated one, according to a 2014 study done by researchers from the University of Maryland, the University of Ottawa, and the American Enterprise Institute, according to a story in Foreign Policy.

The study covered antibiotic and tuberculosis drugs labeled "made in India" and sold in India, Africa, and other non-African middle-income countries and found that 10.9% of the drugs either contained none or less than the required dosage of active pharmaceutical ingredients and of that 10.9%, 7% contained less than the required dosage of active ingredients, Foreign Policy reported.

- here's the story from the Hindustan Times
- and one from Reuters and one from Foreign Policy