The government may give permission to 44 more combination drugs a formulation of two or more active ingredients combined in certain fixed doses – for treating diarrhoea, fever, pain and hypertension, said a health ministry official.
Known as fixed dose combination (FDC) drugs in pharmaceutical industry parlance, these will help reducing the number of pills in a single dosage, and consequently the expenses incurred. For instance, doctors usually prescribe three to four medicines to patients suffering from common cold or diarrhoea. With FDCs, this could be cut down to just one.
Recently, the Drug Controller General of India (DCGI) had turned down requests from several pharma companies for permission to manufacture and market around 294 combination drugs, terming these as irrational.
Now DCGI has granted 44 of them, said the official who didn’t want to be named. These, likely to be approved by June this year, have a market of about Rs 550 crore.
“The proposal is awaiting a go ahead from the Drug Technical Advisory Board (DTAB), which is expected very soon,” he added. The combination drug scene in the country is patchy with no set guidelines available for state drug regulators or the Centre to grant marketing approvals.
According to an industry analyst, the sales of irrational FDC drugs have increased in India in recent years due to lack of proper legislation. “The drug firms are luring doctors with all sorts of unethical means to prescribe these FDCs,” he said.
Medical experts caution that safety profiles of the established drugs will change when they are combined. “The safety of the combination drugs has to be thoroughly evaluated. One cannot mix two drugs whose dosage schedules are not same. Drugs that do not belong to the same class can also not be combined to form an FDC,” according to Dr CM Gulati, who runs a medical journal.
“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 in the past had 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,” an industry official said.
In terms of market share, FDC drugs account for 10% of the Rs 70,000 crore domestic retail pharmaceutical market.