In a new twist to the on-going tussle between the Drug Controller General of India (DCGI) and the pharmaceutical industry in the country over the fixed dose combination (FDC) issue, the Madras High Court has stayed the DCGI order asking the state drug controllers to take necessary action on the FDC issue.

Five Pondicherry based pharma companies moved the Madras High Court under the aegis of Federation of South Indian Pharmaceutical Manufacturers Association (FSIPMA). The companies, along with others, had received notices from the Pondicherry state drug controller asking them to stop production of 294 FDCs listed by the DCGI.

FSIPMA president B Sethuraman said that the High Court order will be a great relief to the pharma industry. Though the signed order is yet to receive, he said the lawyers are debating the issue whether this order will have jurisdiction in Pondicherry only or pan-India effect.

Some lawyers are of the view that since the court has stayed the DCGI order, which in essence is a central government action, it will be applicable to all over India. But, some lawyers opine that since it is a High Court verdict, it will be applicable to the state only, Sethuraman said.

An industry source said that the High Court order will have wider ramifications as almost all the state drug controllers in the country have issued notices to the drug manufacturers to stop production of FDC drugs immediately. Faced with this notice, the pharma companies have only limited options, either move court or stop production. As thousands of crore rupees are at stake, the drug manufacturers have no option but to move court, an expert in the field said.

The High Court order is based on the fact that the pharmaceutical companies which moved the court had proper and valid licenses from the concerned authorities to manufacture these products.

Earlier, the state drug department had served notices on these companies to stop production of fixed dose combination drugs listed by the DCGI. The DCGI had identified 294 FDCs which were to be withdrawn from the market. The DCGI had recently held a meeting at NIPER in Chadigarh between the DCGI and the industry which failed to cut much ice on the issue.

In fact, the legal intervention in the matter was on the cards ever since the DCGI-Industry meeting on October 27 in Chandigarh failed to reach any conclusions. While the industry demanded to continue production of around 150 'need further examination' category drugs, the DCGI insisted on immediately stopping production of all the 294 FDCs identified by him as 'doubtful in quality for human consumption'. As the discussion led to nowhere, some of the industry associations had warned of moving court.