20 April, 2019
New Drugs Exempted from Price Control
The Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals) has, by way of notification dated January 3, 2019, notified an order amending the Drugs (Prices Control) Order, 2013 (‘DPCO 2013 ’). The DPCO 2013 controls and regulates the prices of all drugs (including medical devices) that are sold in India. The salient features of the Drugs (Prices Control) Amendment Order, 2019 (‘Drugs Order ’) are set out below:
i. Exemption of Patented New Drugs from Price Control: The Drugs Order grants all manufacturers of patented new drugs an exemption from price control under the Indian Patent Act, 1970 for a period of five years from the commencement of ‘commercial marketing’ in India. Earlier, such exemption was only available to a manufacturer of patented new drugs (i) not produced elsewhere; and (ii) developed through indigenous research and development. These requirements have now been done away with. The other exemptions under the DPCO 2013 available to a manufacturer producing new drugs in India viz. : (i) by a new process developed through indigenous research and development; and (ii) involving a new delivery system developed through indigenous research and development, continue to remain in force.
ii. Exemption available for drugs treating orphan diseases: The Drugs Order also empowers the Government to exempt from price control, certain drugs that treat orphan diseases. This power was not available under the DPCO , 2013. iii. Collecting and using market based data: The Drugs Order further empowers the Government to obtain price related data on drugs from any company specializing in pharmaceutical market data and allows the Government to validate such data by appropriate evaluations and surveys. Under the DPCO , 2013, the Government had no flexibility and was required to exclusively source such data from IMS Health. The Drugs Order also empowers the Government to use the market data on price of drugs of any given month (as it deems fit), for the purpose of fixing the price of notified drugs, without any rigid requirement of using data pertaining to the previous six months only (as was required under the DPCO 2013)
Eight New Medical Devices Brought under the Regulatory Purview of ‘Drugs’
The Ministry of Health and Family Welfare in consultation with the Drugs Technical Advisory Board has, by way of a notification dated February 8, 2019, introduced eight new medical devices under the purview of ‘drugs’, as defined under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (‘DCA ’). These devices include all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-ray machine and bone marrow cell separator (collectively, ‘Medical Devices ’), and are in addition to the preexisting list of 23 other medical devices defined as ‘drugs’ under the DCA . The Medical Devices will be brought under the regulatory purview of the DCA and the Medical Devices Rules, 2017, with effect from April 01, 2020.
For further information, please contact:
Zia Mody, Partner, AZB & Partners
zia.mody@azbpartners.com
