Two Mumbai-based pharmaceutical companies, IPCA Laboratories Ltd and Aristo Pharmaceuticals Ltd, are known to have bypassed the mandatory new drug clearance requirements to market the fixed dose combination of Aceclofenac and Paracetamol months before the product was approved for the first time for use in the country.

While the approval from the office of the Drugs Controller General of India (DCGI) came on June 29, 2004, both the companies had been marketing their successful brands Zerodol - P and Aceclo Plus, after getting them manufactured by small drug companies based in Tamil Nadu and Pondicherry, it is learnt.

Of the two companies, IPCA Laboratories is yet to receive a DCGI approval for the particular FDC. Aristo was among the four companies who have been given marketing approval by the DCGI in June 2004.

As per the information displayed on the packs of Zerodol-P and Aceclo Plus, sourced from the local market, Zerodol-P was manufactured by Caplin Point Laboratories Limited, Pondicherry in March 2004 (three months prior to DCGI approval of the combination) and Aceclo Plus was manufactured in February 2004 by Maral Labs, Karapakkam, Chennai (four months prior to DCGI approval).

Industry observers point out that similar cases of drug companies marketing unapproved FDCs is on the rise thereby raising serious questions on the efficiency of various state drug control departments to put an end to such practices. When contacted, a senior CDSCO official said that the state regulatory authorities and not the central agency should control such activities. In both the cases, the companies are known to have received manufacturing licenses directly from the state drug authorities.

Meanwhile, responding to a query from a city-based medical journal, IPCA Laboratories has stated that they had indeed received DCGI approval for the FDC in November 2003 itself. The response letter given the "reference number of DCGI approval for FDC of Aceclofenac and Paracetamol as required by Rule 122 E of the Drugs and Cosmetics Rules as ED / AK Jugn / 25 dated 28. 11. 2003.

The company has also indicated that the first launch of Zerodol P was in March 2004. Interestingly, the approval date, as claimed by the company, comes much before the official approval declared by the office of the DCGI on its website. The approval date, as per CDSCO website is 29-06-2004 and the FDC is shown as the 213 rd drug in the list.