Pharma firms seek time to phase out FDCs

The pharmaceutical industry has asked the Drug Controller General of India (DCGI) for more time to phase out fixed-dose combinations (FDCs), a mix of approved drugs, from the Indian market.

The industry has also urged the DCGI to adopt a practical approach and come up with clear-cut guidelines on this issue. "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," said Daara Patel, secretary general of Indian Drugs Manufacturers Association (IDMA).

In June this year, the DCGI had recommended to state drug controllers to cancel licences of 1,105 drug brands, saying they had been launched without its approval.

A new drug has to be approved by the DCGI. Based on the directive, states like Maharashtra, Gujarat and Orissa had asked manufacturers to withdraw products from the markets and seek fresh approval from the DCGI.

The pharma industry has suggested that the DCGI's office should first develop specific criteria for assessing rationality of FDCs, rather than directing state drug controllers to ban the drugs.

All the FDCs have legally valid licenses issued by licensing authorities in the states and most have not reported any serious side effects or fatal cases so far, industry sources claim.

"Our members will challenge the decision in court, if state drug controllers cancel manufacturing licences. Business worth more than Rs 1,000 crore is at stake due to the lack of clarity in the rules. If the rules did not permit it, the drug controllers should not have issued the licences," said TS Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industries (CIPI).

The industry wants the rationally proven FDCs currently available in the market to be legalised by the DCGI, while time limit be set for proving rationality of other drug combinations.

In the interim, companies already manufacturing and marketing these FDCs be allowed to continue production and sale, the industry has demanded.

"Some developed countries like the US rely on '"usage" and "science" to establish rationality. The "usage" is determined by quantitative data on "co-prescriptions" generated by independent organisations doing prescription audit and "science" is based on independent opinions of identified experts in the field. Thus, both objective and subjective elements are used together to determine rationality of an FDC," noted DG Shah, secretary general of Indian Pharmaceutical Alliance (IPA), a grouping of leading Indian pharmaceutical companies.

Meanwhile, sources said blended drugs in fixed doses have to undergo extensive trial in over 30,000 people to be sure that an adverse reaction with an incidence is not missed.

The National Pharmacovigilance Advisory Committee (NPAC) has already asked all peripheral adverse drug reaction monitoring centres to monitor 11 drugs for possible adverse drug reactions, including nimesulide, COX-II inhibitors, analgin, cisapride, phenylpropanolamine, phenylbutazone, furazolidone, statins, droperidol, sildenafil and gatifloxacin.

In case of nimesulide, as many as 17 adverse drug reaction (ADR) cases were reported between 1993 and 1999, they said.