Coronavirus pandemic: Govt delegates more powers to NPPA to control, increase API production by manufacturers

New Delhi: With a recent notification, the Central Government has given powers to the National Pharmaceutical Pricing Authority (NPPA) under the paragraph 3 of the DPCO to excercise control over drug manufacturers to decide on their production of API and give directions to increase production

Confirmation of the same was recently made in the gazette notification issued by the government that stated

In exercise of the powers conferred by sections 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government hereby directs that National Pharmaceutical Pricing Authority, established vide Government of India in the Ministry of Chemicals and Fertilizers Resolution No. 33/7/97-PI-I dated the 29th August 1997, published in Part I, Section 1 of the Gazette of India, Extraordinary, shall also exercise the functions of the Central Government in respect of paragraph 3 of the Drugs (Prices Control) Order, 2013 in addition to the functions specified in the Orders of the Government of India, in the Ministry of Chemicals and Fertilizers number S.O. 1394 (E), dated the 30th of May 2013 and S.O. 528(E), dated 15th February 2016.

The para 3 of the DPCO deals with the Directions to manufactures of active pharmaceutical ingredients or bulk drugs or formulations and states that

The government may,-

(i) with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non- commercial use in the public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and sell such active pharmaceutical ingredient or bulk drug to such manufacturer(s) of formulations and to direct formulators to sell formulations to institutions, hospitals or any agency as the case may be.

(ii) for the purpose of giving any direction under subparagraph (i), call for such information from manufacturers of active pharmaceutical ingredients or bulk drugs or formulations, as it may consider necessary and such manufacturer shall furnish the required information within such time the Government may fix", say para 3 of DPCO states.

To read the full details click on the following link:

https://business.medicaldialogues.in/pdf_upload/pdf_upload-126994.pdf