The pharmaceutical associations in the country are making the last minute efforts to make the Drugs Controller General of India (DCGI) to see reason in implementing his recent order to withdraw irrational combination drugs from the drug market in the country. The DCGI has listed 294 combinations and has directed the state drug controllers to immediately withdraw these products from the market.
Acting on the DCGI directive, the state drug controllers have started issuing notices to the companies to withdraw their products from the market that has provoked the industry which is asking the DCGI to see reason while implementing his decision. Interestingly, industry associations are not against the action, but the way it is being implemented without giving an opportunity to the industry to prove the rationality of their products.
All the industry associations with the exception of OPPI are up in arms against the DCGI's rather hasty decision. Heated discussions are going on in the industry about the next move to be taken in the wake of DCGI action which threatens to make thousands of crore of investments going down the drain.
The associations are preparing to make representations to the DCGI urging him to make a mechanism to withdraw the combination drugs from the market. "Companies are willing to adapt to new situations. But there should be a mechanism to implement it and the industry should be given some time to prove it", said Indian Pharmaceutical Alliance (IPA) secretary general DG Shah. IPA is an alliance of the country's top pharmaceutical companies including Ranbaxy.
In fact, the IPA had proposed a mechanism for implementing the withdrawal of combination drugs from the market.
Supporting the proposal to centralise licensing of FDCs, the IPA had proposed that the starting point for weeding out irrational combinations should be development of criteria for 'rationality assessment'. Some developed countries like USA rely to 'usage' and 'science' to establish rationality. The 'usage' is determined by quantitative data on 'co-prescriptions' generated by independent organisations doing prescription audit. The 'science' is based on independent opinions of identified experts in the field. Thus both the objective and subjective elements are used together to determine rationality of an FDC, the IPA suggested.
The IPA said that the next step should be to classify currently marketed FDCs in two categories of the ones which have adequate scientific rationale and usage and are approved by DCGI and the ones for which rationality to be assessed with reference to the established criteria.
The companies marketing the first category FDCs should be given a letter of authorisation by the DCGI to prevent undue harassment and the companies marketing the second category of FDCs should be asked to establish 'rationality' within a specified time period. In the interim, the DCGI, by issuing a notification, should allow companies already manufacturing or marketing these FDCs to continue production and sale of these FDCs, the IPA suggested to the DCGI.