INDIA BUSINESS WORLD - NOVEMBER 16^th - NOVEMBER 30^th - 2007

COMBINATION DRUGS CAN STAY ON SHELVES, RULES HIGH COURT

Most of the 294 controversial combination drugs that the government wants withdrawn will continue to be sold for now.

The Madras High Court has stayed a central government order to pull out the fixed-dose combination (FDC) drugs from the market. The court was hearing a petition by the Confederation of Indian Pharmaceutical Industries (CIPI), which represents 4,000 small companies, challenging the government move.

The government recently ordered companies, which were manufacturing FDC drugs with licences from respective state regulators, to phase them out without delay. Its argument was that the Drug Controller General of India (DCGI) was yet to give a no objection certificate to state authorities to issue manufacturing licences. With the court order, companies can continue to manufacture with these very licences.

But the order excludes about 15 of the drugs classified as 'banned', said CIPI co-chairman DK Gupta. He said CIPI members account for 40% of the Rs 3,500-crore market for these drugs. Also, the HC order gives relief to 23 industry associations from across India on the issue of combination drugs. Therefore, it is applicable to the whole country, he added.

According to Indian Drug Manufacturers Association (IDMA) (a body representing mid-sized and big companies) secretary-general Dara Patel, the order would be applicable till the next date of hearing, in about eight weeks.

However, it remains to be seen whether state drug controllers will pass on the order's benefit to other big companies who were not party to the legal action but account for the rest of the market.

When contacted, DCGI Dr M Venkateswarlu said, "I have not seen the order. However, we are serious about withdrawing these medicines from the market and if there is a stay on our decision, we would challenge it." The government had earlier indicated that it might even go to the Supreme Court to contest legal setbacks.

IDMA's Mr Patel said his association members had already been asked to stop production and apply afresh for licences for these drugs.

Earlier, five Puducherry-based small drug companies had received a similar stay order from the same court. Small companies who manufacture these drugs for bigger pharma companies claimed before the court that they might have to shut shop after losing their production contracts.