Mumbai, Feb 5: The Delhi high court has extended the stay against initiating any punitive action against pharmaceutical companies with respect to a list of eight drugs following a writ petition filed by the Bulk Drug Manufacturers' Association (BDMA). The stay will now continue till April 8, the expected date of the next hearing.The matter which came up for hearing on February 3 saw the respondents--the Government and the National Pharmaceutical Pricing Authority (NPPA)--file their reply, though the matter was subsequently adjourned. The reply, however, apparently, only furnishes data with respect to two drugs.
The BDMA had earlier alleged that these eight drugs (cefadroxil, cloxacillin, theophylline, trimethoprim, norfloxacin, salbutamol, ciprofloxacin and sulphamethazole) had been "wrongfully" included under the Drug Price Control Order (DPCO).
On January 7 this year, a division bench of the Delhi high court, comprising justice Devinder Gupta and justice JB Goel, had in an interim ruling, stated that, "No punitive action be taken against the members of the petitioner association based upon the inclusion of eight drugs within the ambit of price control." The BDMA represents over 300 domestic drug companies.
The BDMA had taken the Centre and the NPPA to court in protest against the duo's allegedly ad hoc and arbitrary price-control policy.
BDMA had also claimed that the Government had failed to act on the recommendations of both the Hathi Committee and the Kelkar Committee set up to study/review drug-pricing policies. The Hathi Committee report submitted in 1978 recommended that only prices of certain essential and commonly used formulations be regulated. Similarly, the Kelkar committee report, published in 1984, had recommended the exclusion of certain drugs from the purview of price control.
The key criteria for inclusion/exclusion under the DPCO are: 1) drugs under price control should have a minimum annual turnover of Rs 4 crore 2) drugs of popular use, in which there is a monopoly situation, will be kept under price control. A monopoly exists if for any bulk drug, with an annual turnover of Rs 1 crore or more, there is a single formulator with a market share of 90 per cent or more, 3) drugs in which there is sufficient market competition, namely, at least five bulk drug producers and at least 10 formulators and none having more than 40 per cent market share in the retail trade (as per ORG) may be kept outside price control.
Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.