A month after the Madras high court vacated his order asking the state drug controllers to take necessary action on 294 FDC drugs, the Drug Controller General of India (DCGI) will file the counter-affidavit in Madras High Court on December 14 to vacate the stay orders.

DCGI Dr M Venkateshwarlu told Pharmabiz that all preparations are complete to file the counter-affidavit in the court on December 14. He himself is expected to be in Chennai along with the lawyers to file the affidavit to vacate the stay. While permitting stay order on November 11 to five pharma companies of Pondichery, the court had given eight weeks time to the DCGI to file the counter-affidavit.

For the DCGI, vacating the stay orders immediately is significant as he is on the verge of retirement and weeding out of irrational combination drugs is a pet project that he wanted to complete before his retirement. That he has made it a prestige issue is clear from the fact that he used all his resources at his command to force the state drug controllers to act on his orders, the last being the invocation of section 33(p) of Drugs and Cosmetics Act which was also stayed by the court.

The DCGI has to get three stay orders get vacated by the court. In the first case on November 11, the court had stayed the DCGI order on a petition filed by five pharma companies in Pondicherry. As the stay order was limited to only five companies, the court was moved again by the pharma association. In the second instance, the court stayed the order on a petition filed by Federation of South Indian Pharmaceutical Manufacturers Associations (FSIPMA).

To counter these two stay orders, the DCGI decided to invoke section 33(p) of the Drugs & Cosmetics Act, 1940 under which the DCGI directive to the state drug authorities will become binding. The decision to invoke section 33(p) was taken in the wake of the successive stay order of the Madras High Court on the DCGI order asking the state drug controllers to act against the FDC drugs.

But, in a big blow to the DCGI's efforts to phase out irrational combination drugs from the pharmaceutical market of the country, the Madras high court once again stayed the DCGI order invoking section 33(p) of the Drugs & Cosmetics Act, 1940. The court stayed the order on a petition filed by Confederation of Indian Pharmaceutical Industries (CIPI).

Now, the DCGI has to get these stay orders vacated before taking any action against the FDC drugs.