October 23, 2007

Centre plans to phase out `harmful` combo drugs

The Drugs Controller General of India (DCGI) is finalising a strategy to ensure total pullout of irrational combination medicines from the domestic market.

The DCGI has called a meeting of state drug controllers and representatives of the industry to understand the implementation issues related to its recent directive to withdraw the licences issued over the last 10 years for marketing 1,070 brands of 330 fixed-dose-combination (FDC) medicines worth about Rs 1,000 crore.

The three-day meeting, to be held at National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh, from October 25, may lead to the preparation of draft guidelines on FDCs to be followed by all state drug authorities.

Till now, the DCGI’s directive has received only partial response from states. The main reason for this is that all these drugs are being manufactured with approvals from state drug authorities though the marketing approval of FDCs — which by Indian definition come under the new drug category and approval for which is supposed to be given only by the central authority, that is, the DCGI’s office.

A majority of the states, including Delhi, remain hesitant to take action as many of these FDCs are being marketed for over a decade now. The industry is also perturbed due to the fact that these medicines, like drugs for cold-fever-pain, are commonly prescibed by the doctors. The industry wants to weed away all harmful combination of drugs (if any) while keeping intact the marketing rights of effective and safe medicine combinations.

“We have asked the DCGI to legalise the safe FDCs available in the market and to develop specific rules for licensing such drugs. The DCGI’s office has in the past legalised many such drugs. If there are proven harmful combinations, we will support their withdrawal and the industry should be given adequate time for withdrawing such combinations,” said Daara Patel, secretary general of the Indian Drugs Manufacturers Association (IDMA).

Sources in the DCGI office said the apprehensions of good medicines going off the shelves were misplaced as the companies would be free to send fresh applications for marketing approvals to the central office. Given the current licence fees, the DCGI’s office, the Central Drugs Standard Control Organisation, may earn about Rs 3 crore if all the companies apply for central licences on these medicines.

All major domestic pharmaceutical companies, other than Indian arms of foreign multinational firms, have FDCs in the market.

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