Himachal Pradesh High Court stays Drug Controller General of India's order on combination drugs

(7/10/13)

NEW DELHI, 7 OCT 2013: The government's efforts to weed out 'potentially unsafe' combination drugs for which pharma companies have not taken the central drug regulator's permission by September 30 has run into a wall. The High Court of Himachal Pradesh on September 27 granted an interim stay on Drug Controller General of India's (DCGI's) directive of July which intended to dub all those combination drugs as 'illegal' for which drugmakers have not filed safety and efficacy data with the central drug regulator by September 30. The court was hearing an appeal of a member of Himachal Drug Manufacturers' Association. "Some of these drugs are being marketed for over two decades with no adverse impact recorded in the country. Isn't that proof of safety?" said SL Singla, general secretary of Himachal Drug Manufacturers' Association. Drug experts say India has had no scientific mechanism to measure side effects of drugs. "Why can't the government constitute an expert panel which can identify dubious combination drugs and study their safety and efficacy instead of going after all combination drugs?" Singla asked. Combination drugs constitute 46% of the country's Rs 70,000-crore drug market but many of these have not been tested for safety and efficacy and are termed 'irrational' by drug experts. Also, a large chunk of this is being sold with the state drug controllers' consent, but the central drug regulator is kept out of the loop. In January, the DCGI had asked the state drug controllers that drugmakers must submit safety and efficacy data for combination drugs to the central regulator within 18 months. If pharma companies fail to do so, the sale of these drugs would be forbidden in the country, it said. In July, the central drug regulator came out with a similar directive but preponed the deadline to August 30, which it later extended by a month. The central drug regulator said in its July order that despite its January notice, only a few drugmakers have come forward to prove the safety of the combination drugs that they are selling. But the court has noted that the drug regulator has 'unilaterally altered' the deadline without citing any 'exceptional reasons' for doing so. Drugmakers, especially small and medium scale players, are arguing that such an approach to prohibit sale of combination drugs is unfair and would hurt their business. "How can these drugs, which have been approved by the state governments, be considered illegal? In that case, is it the fault of the drug manufacturer or the state drug regulator, which cleared its sale?" another small scale drugmaker said, requesting anonymity. The government is battling another case in Madras High Court since 2007 against drugmakers, where it is trying to convince the court why it's necessary to withdraw 294 'irrational' combination drugs from the market. The government renewed its efforts to phase out 'irrational' combination drugs this year after a parliamentary panel last year criticised the regulator for not acting on such potentially 'unsafe' drugs flooding the market.