The Department of Pharmaceuticals is planning to make another attempt to introduce quality mark on the lines of the ISI or the Agmark approvals for generic drugs manufactured and sold in the country, for ensuring quality of medicines and helping the consumers to identify it.
Though a similar proposal was made by the chemicals department some time back after a working group of the Planning Commission suggested it, the health ministry shot down the move saying that the government cannot introduce separate or different quality marks.
Having initiated earnestly a proposal for setting up generic stores to sell unbranded generic medicines at affordable costs to the poor sections of the society, the department is planning to make this attempt to introduce quality mark for generic drugs. If the attempt gets successful, the generic drugs especially the unbranded generics will have a special quality mark so that people can identify the mark and buy the drugs accordingly, sources said.
The idea of introducing quality mark for generics was first mooted by the Pranob Sen Committee as the country was fast emerging as a major power in generic drug segment across the globe. And with a number of small scale pharma units into manufacturing, the Sen committee suggested something like ISI or Agmark.
The Planning Commission, while preparing the recommendations for the 11th Plan, also backed the idea. The Panel also called for involving industry and the quality registration body Bureau of Indian Standards to set up and maintain a new method of granting quality marks for drugs. These marks should be awarded only on submission of bio-equivalence and bio-availability studies to the DCGI, the panel said.
``It is viewed that the prevailing system of drug certification was completely opaque as far as the therapeutic quality and effectiveness of different brands are concerned, certainly to the patient and also possibly for the doctors. The Indian Pharmacopoeia (IP) certification or its equivalent in other countries, attests the quality of the API in most cases, and not to the quality of formulation, which is what the patient actually purchases,'' the panel said.
The recent meeting between the pharma department and the industry on the generic stores also called for making a system to ensure quality of generic drugs. The pharma department will now consult other agencies also before finalising the details of the proposal and push for approval from the government. The department also wants to make sure that only quality medicines should be sold through the proposed network of the generic stores.