Drugs & Cosmetics Act amended for enhanced penalties to tackle problem of adulterated drugs
New Delhi/March 8
Indian government will fix or regulate prices of scheduled drugs/formulations as per the provisions of the Drugs (Prices & Control) Order, 1995 and no one is allowed to sell these medicines at a price higher than the price fixed by National Pharmaceutical Pricing Authority (NPPA).
Union Minister of State for Chemicals and Fertilisers, Srikant Kumar Jena said that the manufactures of essential medicines will have to consult with NPPA before fixing the prices and they have to seek approval of NPPA. “NPPA will fix or revise the prices of scheduled drugs and no one is allowed to sell any scheduled drug or formulation at a price higher than the price fixed by NPPA. However, in case of other drugs, manufacturers can fix the prices by themselves without seeking the approval of NPPA or the government,” Jena said.
Jena further stated that the trend in prices of non-scheduled drugs will be monitored and suitable action will taken by NPPA where price increase is more than 10% in a period of one year on moving basis. “The Department of Pharmaceuticals has notified the National Pharmaceutical Pricing Policy- 2012 under which the prices of National List of Essential Medicines-2011 (which covers live saving and cancer drugs) are to be controlled and regulated. The objective is to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines ‘essential medicines’ at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of industry, thereby meeting the goals of employment and shared economic well being for all,” Jena stated.
Indian government has also amended provisions of the Drugs & Cosmetics Act, 1940 for enhancing the penalties so as to help tackle the problem of spurious and adulterated drugs. Under the new provisions, the maximum penalty for such crime is life imprisonment along with a fine of Rs 10 lakhs or 3 times the value of the confiscated goods and some of the offences has been made cognizable and non-bailable. Besides officers from the Drug Controller’s Office, other gazette officers also authorized to launch prosecution under the Act and specially designated courts for trial of offences covered under the Act. Moreover, the Act also has provision for compounding of minor offences.