The Hindu Business Line : Combination drugs: Window open for fast-track approval

Mumbai, Nov. 4 Acrimonious protests from some drug-makers notwithstanding, the Drug Controller General of India (DCGI) is firm on keeping some combination drugs that have been classified as absurd, rejected or banned, off chemist shops.

But, in a breather of sorts for drug companies, the DCGI has also kept a window open for fast-track approvals of some combination drugs falling under another category of 150 medicines that have been slotted for review.

The DCGI has assured pharmaceutical companies that his office would clear review applications on certain combination drugs within 30 working days, provided they meet certain specifications, a source familiar with the development told Business Line. Companies will have to submit analytical, stability and bio-equivalence data on the combination drugs, among other things, to get their review applications cleared in a month.

Quick review

Certain nutritional vitamin-based medicines, dermatological preparations, cough and cold, gastro-intestinal and anti-microbial medicines feature on this list slated for a quick review. About 78 combination drugs are on this list, said Mr Daara Patel of the Indian Drug Manufacturers Association.

DCGI directive

The DCGI had stirred a hornet’s nest when his office sent four lists to state authorities about two months ago, outlining rejected, banned, approved and to-be-reviewed-fixed-dose-combination medicines (FDCs). Subsequently, in a late-October meeting, the DCGI said that of the 294 combinations under the scanner, about 120 were to be withdrawn from the market, with no production, and licences suspended. Another 150 were slotted for review by the Centre and here too production had to stop, though companies did not have to withdraw existing combination medicines from the market.

The pharmaceutical industry is largely with the DCGI’s efforts to regulate the estimated Rs 3,000-crore market of FDCs. But, how does one ensure this problem does not surface in another five years, questions Mr D.G. Shah of the Indian Pharmaceutical Alliance, underlining the need for uniform implementation of the DCGI’s directives. Companies’ investment plans on these medicines get disrupted when some State regulators and the Centre do not speak in one voice, he observed.

Though the norm requires new forms of medicine to get regulatory clearance only from the DCGI, some States overlooked this, leading to the present impasse. The IPA, IDMA and the Organisation of Pharmaceutical Producers of India have sought meetings with the Union Health Secretary to urge that companies be allowed to continue production of the 150 medicines needing review, till they are actually examined and a decision is taken to allow or reject them.

Fixed-dose combinations

FDCs are medicines combined in fixed doses to form a single medicine. They are popular in treating HIV/AIDS, for example, reducing the patients’ pill-burden. A three-in-one pill that combines three different medicines in one, allows a consumer to take two medicines a day instead of six.

But combination drugs have been abused too, with some companies making them driven by commercial motives rather than scientific rationale, industry officials admit. This makes the combination medicine ineffective and harmful to the patient, they observed.

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Combination drugs: Window open for fast-track approval