Even as the union health ministry is set to introduce the Drugs and Cosmetics (Amendment) Bill, 2005 in the on-going session of Parliament to invoke stringent penalties like life imprisonment and non-bailable arrest for manufacturing and selling of spurious drugs, the SME Pharma Industries Confederation (SPIC) has sought Prime Minister Dr Manmohan Singh's intervention in the matter to safeguard the interests of legitimate manufacturers.

Highlighting the lack of safeguards for legitimate manufacturers in the proposed Bill, SPIC secretary general Jagdeep Singh in a letter to the PM said that one major lacuna in the Bill is the lack of definition on substandard drugs. Since there is no separate definition of substandard drug in the proposal, if any drug is found substandard the manufacturer will be charged for manufacturing and selling of adulterated or spurious drugs. Since this is a non-bailable offence, the manufacturer will be arrested and by the time he proves his innocence it will be months, or even years.

It is a known fact that anti-social elements produce spurious drugs using labels of licensed manufacturers. Instead of devising methods to track down on such activity, a new law is being brought which will punish honest manufacturers without any provisions to safeguard their interests. The industry will be open to harassment, as one will not have a chance to prove himself / herself when such a charge is framed except in the court of law.

To begin with, the government analyst testing facilities have not kept pace with the progress made by the pharmaceutical industry owing to financial constraints in some states. For this reason many reports issued by government analysts have been found wrong after being challenged. But with implementation of the said Amendment, arrest will be made on the basis of a test report issued by such a government testing laboratory and an honest manufacturer will have to bear the stigma despite being innocent.

Testing is a complex subject. Many reports of substandard drugs may, in fact, be a result of improper methods of analysis / use of improper chemicals or reagents / incorrect interpretation of prescribed standards / improper storage conditions after a drug leaves the manufacturing premises owing to lack of regular supply of electricity / simple blackmailing in the market place or degradation owing to poor conditions in transportation or stores in temperatures of 45 degrees Celsius.

Despite adequate pre-formulation development studies before the drug is marketed and adequate in-process controls exercised by the manufacturers during the process of manufacture, a drug manufactured as a standard drug may become sub-standard any time. For example, even if a drug is formulated properly under GMP conditions with proper in process controls and the stability studies have also been done before marketing the formulation, it is likely to deteriorate on adverse storage and may fail in one or more parameters. There is a provision in the Act to audit the reserve sample and recall when found necessary. This is a worldwide phenomenon.

But the proposed amendment negates every established process and it does not even take care of the adverse effects it is going to cause on legitimate manufacturers who follow proper systems as per the Drugs Act as well as professional ethics. Certain problems can arise out of day-to-day operations which are beyond the control of the manufacturer who is only one part of the total chain. But the sole responsibility has been placed on the manufacturer in the proposed Amendment.

If no provision is made in the proposed Amendment to safeguard legitimate and genuine manufacturers, most will be forced to exit the profession and very few players will remain in the field of pharmaceutical manufacturing in times to come, SPIC said.