India targets drugmakers with wave of inspections
- India's health authorities are ramping up inspections of drug firms, just as the government moves to revise its laws for medicines.
- The Drug Controller General of India is targeting around 200 drugmakers for inspections including domestic majors like Cipla as well as international firms such as Pfizer, reports The Times of India.
- Regulators in the U.S. and Europe have heavily scrutinized manufacturing facilities in India over concerns of poor quality and compliance lapses. Yet India's generic drugs industry supplies many of the world's cheap drugs and is an important sector for the country's economy.
The planned inspections would represent a significant commitment to improving compliance and manufacturing standards among India's drugmakers.
According to The Times of India report, 36 plants have already been inspected with 20 more planned. Inspections will be focused at sites with prior violations.
The scrutiny follows an attempt by the Indian Health Ministry to ban over 300 fixed-dose combination drugs in March. Drugmakers, however, pushed back against the ban and won a temporary stay from the Delhi High Court.
It also comes as the Indian government is working to revise the existing regulatory framework for medical products in the country, laid out by the Drugs and Cosmetics Act of 1940.
In a statement posted by the Prime Minister's office Wednesday, the government said it would "comprehensively review the existing law," aiming to make it easier for companies to do business while improving the quality of medical products.
Efforts had been made to revise the law through amendments but the Union Cabinet, chaired by Prime Minister Narendra Modi, decided to withdraw the legislation.
While India's drug industry is already large, the government clearly sees room for expansion. "The Indian medical products sector is poised for exponential growth in the near future," the statement said.