Thousands of small drug manufacturers in the country have sought prime minister Dr Manmohan Singh and Congress president Sonia Gandhi's intervention to save them from the serious implications of the recently notified Spurious Drugs Bill which the SSIs described as more stringent than POTA and TADA.

The union health ministry on August 10 this year had notified the Drugs Act Amendment Bill along with guidelines, enhancing the punishment to 10 years imprisonment and a fine of Rs.10 lakhs for production and sale of spurious drugs. Under the Act, production and sale of spurious drugs is a cognizable and non-bailable offence.

Alarmed over the development, SME Pharma Industries Confederation (SPIC) has sought the intervention of the prime minister and the Congress president) to amend the Bill further to make the guidelines legally binding, stipulating only departmental action against the genuine drug manufacturers, except those who are habitual defaulters and those who are nabbed by Vigilance department.

The SSIs regret that in spite of the government's earlier categorical assurance to make the guidelines legally binding to address the concerns of the genuine licensed drug manufacturers, the ministry did not keep its words as legal experts in the pharma field are of the opinion that the new guidelines issued along with the notification by the ministry is not binding on the drug authorities, just like the 1993 DCC guidelines.

SPIC in its letter said that there are provisions in the guidelines of the Bill to separately deal with clandestine spurious drug makers who are major culprits. The provisions for miniscule licensed manufacturers who indulge in spurious drug making as a habit should be based on Vigilance and not on test reports as the Testing Laboratories of most states are ill-equipped as they do not have proper buildings, staff, instruments or expertise to test samples.

For the licensed manufacturers, each one of whom invests around Rs.20 crore on an average, departmental action like cancellation of permission to manufacture the medicine is sufficient in case of grossly substandard drugs. The cancellation of manufacturing license remains the ultimate option whereby the SME loses the entire investment.

It said that the implication of the new Act will be serious on genuine drug manufacturers. Since getting bail is almost impossible and guidelines not legally binding, the fear of prosecution will always hang as the proverbial Sword of Damocles over the head of the drug manufacturers. Major producers of spurious drugs are clandestine operators who ought to use labels of licensed manufacturers. When such drugs enter the chain, the manufacturer whose labels are misused shall face prosecution despite being innocent.