Covid-19 Impact: NPPA asks drugmakers to submit availablility data of 58 APIs, details
New Delhi: In the light of coronavirus outbreak worldwide, the apex drug regulator National Pharmaceutical Pricing Authority (NPPA) has identified 58 significant APIs for monitoring of their availability to prevent any shortage of drugs in India and to take preventive measures over illegal hoarding and black-marketing in the country.
For the same Rajesh K. Agrawal, Director (M&E), has recently directed all importers of APIs/manufacturers of formulations and APIs/ stockists to submit information about these drugs in the prescribed format.
The move comes in line with the recent direction of the NPPA to all the state drug regulators to ensure that that there is no shortage of drugs due to black-marketing and hoarding is their specified area.
"The outbreak of Coronavirus (COVID-19) in China which affects the availability of key Active Pharmaceutical Ingredients (APIs) / Key Starting Materials (KSMs) in India. As part of public health preparedness in respect of APIs / Intermediates /KSMs which are imported from China, a Committee was constituted by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers vide OM No. 35022/4/2020-Policy dated 06.02.2020.," the memorandum statedx
" Accordingly, in pursuance of the powers laid down under Para 29 of DPCO, 2013, all importers of APIs/manufacturers of formulations and APIs/ stockists are directed to submit the information in the prescribed formats (enclosed) (Form-A for merchant importers and Form-B for Indigenous manufacturers/stockists), duly signed by the authorised person.The above information, as on 29th Feb, 2020, shall be submitted before 3rd March, 2020 along with soft copy in excel format of the same at the following email Ids firstname.lastname@example.org, email@example.com.", the memorandum further directed
The memorandum was sent to various State Drug Controllers (SDCs), to ensure the compliance fo the order.
A copy was also sent to organisations such as IPA, BDMA, OPPI, IDMA, FICCI, CII, FOPE for wider dissemination or the order asking them to ensure compliance of the same
To check out the full list of 58 APIs click on the following link
To check out the prescribed format for importers, click on the following link
To check out the prescribed format for Indigenous manufacturers/stockists, click on the following link