Close on the heels of its order last week which stayed the DCGI order asking the state drug controllers to take necessary action on the FDC drugs, the Madras High Court has granted stay on the controversial order again today. The court was moved by Federation of South Indian Pharmaceutical Manufacturers Associations (FSIPMA).
According to FSIPMA leaders, the court has stayed the order of the Drug Controller General of India (DCGI) which asked the state drug controllers of the country to take action against the FDC drugs. However, the court order is yet to be received.
Experts are of the view that the High Court order will have all India jurisdiction as the court has stayed the DCGI order which in essence is a central government order. However, debate on the jurisdiction is on.
On November 7, five pharma companies in Pondicherry had moved court and got stay. These pharma companies, along with others, had received notices from the Pondicherry state drug controllers asking them to stop production of 294 FDCs listed by the DCGI.
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 The DCGI had identified 294 FDCs which were to be withdrawn from the market.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 discussions, led to nowhere, some of the industry associations had warned of moving court.