Hoechst Marion Roussel Limited, the Mumbai-based pharma major, is planning to approach the Drug Controller General of India to seek approval for exports of fixed dose combinations (FDCs) containing metamizol, a drug popularly known as analgin.

The government has banned domestic consumption as well as exports of fixed dose combinations containing analgin. As per the gazette notification GSR 405E, dated 13 October 1995, analgin FDCs with any other drug other than those containing anti-spasmodics were only permitted to be sold in India. However, the government issued another notification (GSR 405 E) dated 3 August 1999, wherein the clause "other than anti-spasmodics" was deleted. In effect, this means that no combinations of analgin can be sold in the country or exported.

In response, the erstwhile Tata Pharma (now part of Wockhardt) filed a petition in the Supreme Court challenging the restriction imposed on the export of analgin. The Supreme Court, in its recent judgement, has ruled that Tata Pharma be allowed to export analgin formulations even if the drug is banned in India.

Hoechst now hopes to cash in on the Supreme Court’s ruling. Ramesh Subrahmanian, executive director (finance) Hoechst Marion Roussel, while interpreting the SC ruling, says, "We are in the process of checking whether we too can resume exports. Ideally, if it is allowed in one case, it should be possible in all cases."

Industry sources say analgin used to be a big money spinner for the company, contributing 30 per cent to the company''s total export turnover. "Analgin continues to be in great demand outside India, and we would consult with the DCGI to find out if a separate application needs to be made, and whether the DCGI prefers a case-by-case approval," Mr Subrahmanian says.

Following the export restriction, Hoechst Marion Roussel''s parent company shifted the production of analgin fixed dose combinations to another country, "which can be restored once the approval comes through", says a pharmaceuticals industry analyst.

However, it is open to interpretation on whether the SC ruling can be taken as a guideline for exports of similar fixed dose combinations containing other banned drugs. A case in point is Festal, another such combination containing an enzyme, pancreatin, that is used for digestion.