The dispute between the pharmaceutical industry and the Drug Controller General of India (DCGI) over fixed drug combinations (FDCs) is worsening, with several pharma companies set to move the court against the stand of the DCGI. The DCGI had asked the various state food and drug administrations (FDAs) to pull back more than 1,000 combination drugs, citing the reason that the combinations are irrational.
A number of member companies in leading pharmaceutical associations in the country, Indian Drug Manufacturing Association (IDMA) and Indian Pharmaceutical Alliance (IPA), are learnt to have decided to file legal suits against the government as their last resort, if the matter is not settled amicably. A meeting of the industry with health ministry officials is expected to take place soon to resolve the issue.
Despite repeated requests from the industry for more time, the DCGI has taken a decision to cancel, with immediate effect, the licenses of about 1,000 combinations drugs, most of which are approved by various state FDAs, industry leaders lament. M Venkateswarlu, DCGI, told FE, ?We are working to sort out the issue. I cannot comment on it right now. Only by the end of this month can anything be said on this.?
Dara B Patel, secretary general, IDMA, said, ?There is no uniformity in the manner the state FDAs act. A few companies received notices asking to discontinue production, while some others were asked to explain why their drugs should not be pulled out of the market. IDMA has not recommended companies to go for legal action. But companies that will be affected by DCGI?s action may adopt the legal route.? IDMA has fixed a meeting with the DCGI on October 24, and a final action on the matter will depend on the outcome of this meeting, he added.
Out of the total number of 1,114 combination drugs that the DCGI has asked to pull back, 1,067 have been approved by various state FDAs but not by DCGI, 35 were rejected by DCGI, while 12 were banned.
?There should be a transparent criteria for approving the combination drugs. Also, an expert committee should be formed to examine the issue. All those drugs found irrational should be referred to the committee and we should be given an opportunity to explain our part,? said a senior company executive.
?The companies, marketing drugs with sufficient scientific rationale and also approved by the DCGI, should be given a letter of authorisation by the DCGI while the companies selling drugs without rationale should be demanded to establish the rationale within a specific period of time,? says another association member.
?Each state FDAs has its own criteria. The norms vary from state to state. That?s why we are asking the government to have common guidelines for combination drugs across the country,? he added.