The battle between the Drug Controller General of India (DCGI) and the Indian pharmaceuticals industry over the withdrawal of close to 1,000 brands of fixed drug combinations seems to be heightening. On Tuesday, five small-scale pharmaceutical companies have approached the Madras High Court seeking a stay order on DCGI?s decision to withdraw 294 fixed drug combinations (FDC). These companies, based in Chennai, have filed suits against the DCGI and the drug controller, Pondicherry, who issue drug licenses in the state, in the high court.
When contacted, M Venkateswarlu, DCGI, told FE, ?Let the companies go to court. My decision was aimed at consumers’ safety. I hope the court will understand my intentions clearly.?
In their suit, the companies, who are members of CIPI (Confederation of Indian Pharmaceuticals Industry), have requested the court to issue a stay order on DCGI’s decision citing reasons that the drugs have been around for 5-10 years and their immediate withdrawal may affect patients badly.
More companies from various states are learnt to be filing cases against DCGI’s action. CIPI has about 3,000 members.
In a meeting that took place with industry associations last month, the DCGI had asked the industry to submit data for 150 drug combinations to substantiate the latter?s claim that those are not irrational combinations. Companies were also asked to withdraw the remaining combinations.
However, companies that have decided to go the legal way, say that although they were ready to submit data to prove the rationality of the drugs, the DCGI had not given them enough time. The market for the 1114 brands is about Rs 3,500 crore.
