In the light of DCGI's nationwide survey revealing the fact that only less than 0.4 per cent of the drugs marketed in the country are spurious, more than 5000 SSIs have once again urged prime minister Dr Manmohan Singh to make the guidelines of the recently notified Spurious Drugs Act legally binding so that only departmental action is applicable to legitimate manufactures unless they are habitual offenders.
The SSIs have argued that media has been widely misused to trumpet exaggerated figures of spurious/fake drugs and evoke concern of public and law makers to push the Spurious Drugs Act Amendment Bill, increasing prison term to 10 years and a fine upto Rs10 lakh. The facts, however, are otherwise as was revealed by the government survey which had collected 24,000 samples out of which around 10 were found to be spurious. As the Bill was passed before the results of survey, the vested interests have achieved what they wanted by misusing the media and creating panic among consumers.
But, for the more than 5000 small units, it has become a nightmare. There is a lack of cold chain in India as electricity is scarce. When temperatures soar to 45-50 degree celsius it can result in significant deterioration of medicines, 90 per cent of which carry the storage stipulation of 25 degree celsius. When a sample is found substantially deteriorated, the legitimate manufacturer will face serious consequences.
Besides, very few sates have proper testing labs, instruments, skilled manpower and technology. But reports generated by such labs can make a legitimate manufacturer face serious consequences. Major producers of spurious drugs are clandestine operators who ought to use labels of licensed manufacturers. When such drugs enter the chain, the legitimate manufacturer whose labels are misused shall face serious consequences. Moreover, no arrangement has been made for funding upgradation as per Schedule M. The Pharma Technological Upgradation Fund was turned down as late as March 2009. But a legitimate manufacturer shall face consequences for not having upgraded to Schedule M, something impossible to do impeccably.
Urging the prime minister to interfere in the matter immediately, SME Pharma Industries Confederation (SPIC) said that before implementing the Bill, it was promised by government that binding guidelines would be provided to safeguard legitimate manufacturers in view of above especially when it was pointed out that such guidelines of 1993 were rarely followed. Surprisingly, the guidelines of the Bill are neither sufficient nor binding while the offence has been made cognizable and getting bail will be impossible for a legitimate manufacturer for no fault of his.