In a significant development in the ongoing DCGI-Industry row over the FDC issue, the Madras High Court has once again given a stay to the controversial DCGI order which asked the state drug controllers to act against the 294 fixed dose combination (FDC) drugs. The court was moved by Confederation of Indian Pharmaceutical Industry (CIPI).

The court order will have wider ramifications as the order will put to an end to the debate over the jurisdiction of the court stay. Since CIPI is a national association representing 3000-odd pharma companies spread across the country, most of them small and medium companies, the jurisdiction will be all over the country.

In fact, this is the third time the Madras High Court has stayed the DCGI order in this month. Earlier, the court had allowed stay on petitions filed by five companies in Pondicherry and then by the Federation of South Indian Pharma Manufacturers Association. In both the cases, lawyers were divided over the jurisdiction of the stay. The stay order to the CIPI on November 27 put the debate to rest.

Commenting on the court stay, copy of which is yet to be received, CIPI chairman T Jaishankar said that the court order will have jurisdiction all over the country as the CIPI members are spread across the country. As many as 24 state associations are affiliated to the CIPI. He said the stay order will be given to the state associations to forward to the state drug controllers to prevent them from taking further action on the DCGI order. Even after the first two stay orders, the Maharashtra FDA commissioner was on record saying that the state drug department will take actions as per the DCGI order. But, the stay order given to the CIPI might force him to reverse his stand.

In yet another development, industry sources said that the Indian Drug Manufacturers Association (IDMA), representing mostly big pharma companies, is also contemplating to move court as a last resort. The IDMA is learnt to be meeting on November 29 to take a final decision on the matter. Though the IDMA has been avoiding a direct legal fight with the DCGI fearing reprisals, the IDMA is bolstered by the successive stay orders given to other organizations, sources said.