The decision of the Drug Controller General of India (DCGI) to withdraw about 1,000 drug combination brands from the country?s pharmaceuticals market has faced a setback. On Wednesday, the Madras High Court has passed a stay order on the DCGI’s action while hearing a case filed by five Chennai-based SSI pharma companies.
Citing various reasons, including that these drugs have been available in the market for a long time, the court said that the DCGI’s order to withdraw these brands is not valid and therefore, these companies can continue production of the barred drugs.
According to experts, the judgment can be applicable throughout the country as the case involves the government of India. The DCGI can go for an appeal in the HC against the stay. Repeated attempts to contact M Venkateswarlu, DCGI, proved futile.
Several large and medium domestic pharma companies, whose drugs have also fallen under the DCGI’s axe, can also now breathe easy, and many are awaiting the copy of the court order. The copy of the judgment is expected on Monday.
On November 7, FE had reported that five Chennai-based small-scale companies have filed suits against the DCGI and the drug controller, Pondicherry in the Madras HC seeking a stay order on the DCGI’s decision. These companies had argued that the drugs in question have been available in the country for many years and their immediate withdrawal may affect patients badly.
The total market for the 1,114 brands that has come under DCGI?s scanner is pegged at Rs 3,500 crore.
The DCGI had ordered the withdrawal of about 1,114 brands of drugs that come under 294 different combinations.
Later, in a meeting with industry associations last month at NIPER, Mohali, he had agreed to check the data that can be submitted for 150 drug combinations to substantiate that those are not irrational, while companies were asked to withdraw the remaining combinations.