The DCGI has agreed to give product license to 75 of the 150 'under examination' category FDCs if the manufacturers alter the strength to therapeutic dose of their products. The DCGI had earlier agreed to give licenses to around 70 of the 150 'under examination' category FDCs if the manufacturers can provide the stability data.

The DCGI Dr M Venkateshwarlu has given an assurance to this effect to a delegation of Confederation of Indian Pharmaceutical Industries (CIPI), an association of thousands of small pharma companies, on October 30. The delegation was led by CIPI chairman T S Jaishankar.

DCGI's this decision will tantamount to giving in principle the product license to 150 of the 294 FDCs for which he had directed the state licensing authorities to withdraw product licenses. The DCGI had also agreed to accept license applications for these products in groups instead of individual applications by the companies.

Earlier, the DCGI had divided the 294 FDCs into several categories like Absurd, Rejected, Banned, Under Examination, etc. The industry associations have more or less agreed to discontinue around 120 products falling under Absurd, Rejected and Banned categories.

Jaishankar said that out of 294 FDCs, 150 FDCs are under consideration for review. Of this, 75 FDCs will only require stability study data. For the other 75 FDCs, the manufacturers need to alter the strength to therapeutic dose. "For example, we have to increase the content of Lacto-Baccilus to standard therapeutic dose and submit again. Similarly products containing Methylcobalamine combination with Vitamins would require increased content of vitamins to have right therapeutic dose", he said.

Meanwhile, the CIPI chairman said that the industry is going to lose a lot as the DCGI did not give in to the demand for continuing production of these 150 FDCs till the manufacturers get their new licenses from DCGI office in Delhi. The industry may move court in this regard. "I have also indicated that we shall go to Court for which the DCGI said that he has no objection and that he will abide by the Court decision", Jaishankar said.