The Hindu Business Line : Combination drugs: Controller to file affidavit

New Delhi, Dec. 5 The Drug Controller General of India (DCGI) will be filing a counter affidavit in a week’s time to the stay orders it has received from the Madras high Court against its plans to take the 294 fixed dose combination drugs off shelves.

The DCGI, re-looking into the rationale of about a 1,100 drugs amounting to Rs 3,000- 3,500 crore in sales that are available in the market “illegally”, has filed caveats in courts in Himachal, Punjab, Haryana and Chandigarh. This follows the stay orders granted by the Madras High Court following a plea from the Confederation of Indian Pharmaceutical Industry against the DCGI’s plans to get these drugs off the market.

Banning the combinations on grounds of public interest is not an option since their efficacy and safety have not been proven yet, said Mr M. Venkateswarlu, DCGI.

The burden of proving their efficacy is with the manufacturer, he added.

Post-1988 fixed- dose combinations require approval from the Central regulatory authority. The drugs in question were in the markets with licences from the state regulator.

The Indian Drug Manufacturers’ Association (IDMA) has, however, advised it members to legitimise their drugs by applying to the DCGI, said Mr Daara Patel, Secretary General, IDMA. Licences for certain combination vitamins are likely to be granted.

Mr Venkateswarlu, however, believes that “manufacturers are being driven by the market. And looking at how much more they can sell to their doctors, or ways to outsmart the drug pricing order.” Combining formulations to be taken on an empty stomach with those to be taken after a meal, or formulations prescribed for adults with paediatric ones, are unacceptable to the DCGI.

However, he was also of the opinion that fixed dose combinations that justify their efficacy and safety are needed for a country like India. Low literacy levels, he explained, affect compliance which is better ensured with fixed doses.