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Govt targets 500 combination drugs, confrontation with pharma companies looming

After banning 344 combination drugs earlier this year, the government has turned its attention to another 500 such medicines, setting the stage possibly for another round of confrontation with thepharma industry.

According to a person familiar with the development, the central drug regulator has sent letters to nearly 300 companies, which have sought marketing approvals for fixed dose combination (FDC) drugs. Some of these firms have been issued show-cause notices and asked to conduct Phase IV trials — a post-marketing study — as evidence to show their products are safe and effective.

But in a sign that the government is not taking a totally adversarial stand on the issue, some companies have been granted no-objection certificates (NOCs) for their products. The exact number of approvals could not be ascertained. Pfizer has received a letter granting it an NOC, a company spokesperson confirmed to ET. The company did not reveal the name of the combination drug for which the letter was issued.

An FDC is a cocktail drug of two or more therapeutic ingredients packed in a single dose. In March this year, the government had decided to ban 344 FDCs that it found to be irrational and unsafe. The move shook the industry, triggering a deluge of court cases by drug makers to obtain a stay on the ban.
The banned FDC market was valued at Rs 3,535 crore in June, according to market research agency IMS Health. Several companies with the largest share of the banned FDC market reflected a reduction in sales of these drugs between May and June, with some seeing up to 30% drop in sales.
"This is the second list (of FDCs) for which examination is complete," said a government official. "Some drugs have been found to be irrational and, so, show-cause notices have been issued (to the companies)."
The official did not divulge the names of companies that had received the show-cause notices, the number of such notices and the names of FDCs. The expert body is currently examining around 50 more FDCs, said the official.

Various applications filed by manufacturers since 2013 have been examined in consultation with an expert committee constituted for the purpose, states a notification from the Central Drugs Standard Control Organisation, dated October 14. "Based on such examination, decisions on the applications for issuance of NOCs for continued manufacturing and marketing/ show-cause notices/letters for conducting Phase IV trial have been taken," the notification said.

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