The SME Pharma Industries Confederation (SPIC) has expressed anguish over the constitution and composition of the working group on scientific and technological measures to counter spurious drugs, and has called for the suspension of the functioning of the group which has already met a couple of times.
In a letter to the principal scientific adviser to the government, the association representing the small scale unit has also taken objection to the appointment of an industry official in the panel. The working group on the scientific and technological measures to counter spurious and substandard drugs and diagnostic centres was set up under the office of the principal scientific adviser to the government.
It also pointed out that the Mashelkar Committee had not called for any technological measures to counter the spurious drugs, contradictory to the context and terms of reference of the working group. "In fact what the Mashelkar Committee noted was that the problem of spurious drugs has been wildly exaggerated and asked for a Government Committee to ascertain the exact extent of the problem," SPIC vice chairman Lalit Kumar Jain said in the letter.
"The constitution of the Working Group to make a norm setting recommendations on an issue rejected by the government at an international forum goes against the government's stand at WHO. Thus the constitution of the Working Group on this issue is not only a contradictory stand but also a matter of grave concern," the letter said, while detailing the steps through which the government recently opposed the move by IMPACT to redefine counterfeit drugs.
"To add to the above-mentioned concerns we are worried about the structure of the panel. One of the members of the Working Group is Dr Praful R Naik, chief scientific officer of Bilcare, one of the leading firms in pharmaceutical packaging. Since many of the technological measures to counter spurious/counterfeit medicines related to packaging and Bilcare is one of leaders in anti-counterfeit technologies, the company has commercial interest in the issue of technological measures against spurious and substandard drugs," the letter said.
The association has urged the principal advisor to ascertain the gravity of spurious drugs and then take a decision whether it needs technological and policy intervention. "Make all the deliberations of the working group public including the minutes and presentations of all meetings the Working Group including the presentation made by Dr Naik on March 9, 2009. Organize an open and transparent discussion with all the stakeholders including, manufacturers, wholesalers, retailers, consumer groups to discuss whether there is a need to address the issue of spurious drugs through technological measures and its implications on access affordable medicines," the association urged.