Pharmaceutical companies and their associations, rattled by the DCGI stand on 294 irrational combinations, are approaching various educational institutions for producing data to support therapeutic claims of their products. Only after submission of technical data and convincing the DCGI, these controversial products can remain in the market.
The Tamil Nadu Drug Manufacturers Association has already approached Madras University in this regard. Individual companies are approaching certain private laboratories for getting such technical data, it is learnt.
The DCGI has divided the 294 FDCs in different categories. While some products will be given licenses on producing BA/BE (bio-availability and bio-equivalence) data, the license for some other drugs will be allowed on production of only stability data. For some drugs, the DCGI has asked for clinical trials.
According to a rough estimate, the manufacturers have to spend around Rs 3 lakh on every product for getting license from the DCGI office in Delhi. As this is a huge amount from the small pharmaceutical companies point of view, the association has taken the initiate to get the data at cheaper rate.
Tamil Nadu Drug Manufacturers Association president B Sethuraman said that the association has already started discussion with the Madras University for getting the necessary data done at a cheaper rate. The Industry department of the state government is also involved in the discussion. The Madras University has all the necessary facilities for conducting all types of tests and providing data to the drug manufacturers, he said.
This will be a good financial support to the drug manufacturers, especially to the small players, as otherwise they have to get the data done from the CROs in Chennai, Bangalore, Hyderabad or Ahmedabad which is must costlier. Though the financial details are yet to be worked out, it will be much cheaper than the CROs, Sethuraman said.
The drug manufacturers are in a hurry to get the data of their products to submit the same to the DCGI office in Delhi. The DCGI has asked for the discontinuation of the manufacturing of 294 FDC drugs till they get the proper license from his office.