The DCGI's invocation of section 33 (p) of Drugs & Cosmetic Acts, which is binding on the state drug authorities, will not have much effect in Maharashtra as the state Food and Drug Administration (FDA) has fully complied with the DCGI order well before the latest Madras High Court order which prompted the DCGI to invoke section 33 (p).
According to senior FDA officials, the state FDA has acted as per the directives of the DCGI before the Madras High Court order. "We have fully complied with the DCGI order and we are also conducting surprise inspections to verify that the manufacturers have complied with the FDA orders," a senior FDA official categorically said.
As per the DCGI order, the state drug authorities have to launch action against combinations classified as absurd, rejected and banned drugs (around 120 FDCs) at the wholesale and C&F agent levels and have also to take action against around 150 Need further Examination category FDCs only at the C&F level."
The FDA official said that once the haze cleared over the Madras High Court stay given to five pharma companies based in Pondicherry, the FDA had taken action on the DCGI directive. The FDA had written to all the companies to withdraw their products falling under the categories of absurd, rejected and banned drugs at the wholesale and C&F agent levels and also directed the companies to withdraw their products falling under the Need further Examination category at the C&F levels. "All the companies have withdrawn their products as per the FDA order. We are verifying the veracity of the compliance through surprise inspections," the official said.
On another earlier FDA directive, all the pharma companies in the state had stopped manufacturing of all the 294 FDC drugs identified by the DCGI.
Meanwhile, the FDA official said that the drug department did not initiate any action at the retail level so far as the minutes of the DCGI-state drug controllers meeting held in Chandigarh on October 26 does not mention anything about the action at retail level. As per the decision taken at the Chandigarh meeting, the SLAs have to ensure that all the brands of the 120 FDC drugs falling under the category of absurd, rejected and banned have to be removed from retail chemists also. "We are blindly following the DCGI order. Now everything is in black and white," he said.