The small and medium pharma enterprises (SMEs) will soon approach the Task Force on SMEs, constituted by Prime Minister Dr Manmohan Singh to resolve the issues plaguing the small and medium sector in the country.
Though there are several hey issues that plague the SME pharma sector in the country, two major issues that will be specially brought to the notice of the Task Force, headed by TKA Nair, will be the notification of the Drugs and Cosmetics (Amendment) Act and the centralisation of Certificate of Pharmaceutical Product (CoPP) by the DCGI. The SME pharma companies in the country look at these changes made by the government as part of a bid by the vested interest to eliminate the around 5000 pharma SMEs in the country.
Recently, union health ministry had notified the Drugs and Cosmetics (Amendment) Bill stipulating stricter penalties for manufacturing and marketing spurious drugs. Besides, the offence has been made a non-bailable one. By amending the Act, the government was eager to clean the country's drug market of spurious drugs. But, the industry is wary of the unintended consequences and the resultant harassment to the licensed and bonafide manufacturers.
Major concern of the industry in the Bill is the lack of provisions to safeguard the interests of the genuine drug manufacturers. There is no mention of definition on substandard drugs in the Bill. Since there is no separate definition of substandard drug in the Bill, if any drug is found substandard the manufacturer will be charged for manufacturing and selling of adulterated or spurious drugs. Though the government has come out with a guidelines in this regard, the ministry did not notify it, thereby not binding on the authorities to follow.
Meanwhile, the SMEs argue that the pretext of removing spurious drugs seems hollow as the figures show there are less than 0.4 per cent spurious drugs in the country (as per annual data of four years) and as per Special Drive conducted for the purpose by the DCGI which found only 11 spurious drugs out of 24,000 samples lifted and tested.
On the CoPP issue also, the SMEs argue that a Uniform Format and not centralization can be the best remedy in a vast country like India. Instead of centralization, the answer is creation of a common format which can be circulated to all states to which exporters have no objections. Handling 35 states by a centralized office will always remain a challenge and delays are imminent. Exports are time bound, delays are disastrous as they result in cancellation of orders which tantamount to handing over the market to China on a platter who is better placed in view of its low priced APIs.