India may bundle fixed-dose drug challenges for top court ruling

Mixed pills

India may ask the country's top court to rule on a bundle of legal challenges to a previous move by a drug regulator in March to ban more than 300 forms of combined medications.

The Times of India said that as many as 180 cases are in various stages in lower courts, challenging orders by the Drug Controller General of India to ban 344 so-called fixed-dose combinations of separate drugs.

The issue came before India's lower house of Parliament last week with Health Minister J.P. Nadda saying he would seriously consider a suggestion to club all of the cases together and head to the Supreme Court for an expedited and presumably final ruling.

Reports suggest the ban could cost drugmakers, foreign and domestic, a cumulative INR38 billion ($570.7 million). The regulator banned the combinations citing a lack of new clinical trials in many cases for formulations running into the thousands--many of which are approved at the state level.

But the local drug industry has moved quickly to launch appeals through court filings, especially with as many as 1,700 more fixed-dose products under review for safety.

- here's the story from the Times of India
- and one from the Economic Times

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