National Pharmaceuticals Pricing Authority (NPPA) has directed merchant importers, stockists, manufacturers of active pharmaceutical ingredients (APls) and formulations to submit data of 58 APIs by March 3, 2020 to prevent illegal hoarding and black marketing in the country.
The drug pricing regulator’s directive comes in the wake of outbreak of coronavirus (COVID-19) in China which has affected availability of key APls and Key Starting Materials (KSMs) in India.
A committee constituted by the Department of Pharmaceuticals (DoP) identified 58 APls imported from China for monitoring of their availability and to take preventive measures over illegal hoarding and black marketing in the country.
NPPA took this decision in pursuance of the powers laid down under Para 29 of Drugs Price Control Order (DPCO)-2013, which stipulates that all importers of APls, manufacturers of formulations and APls and stockists are directed to submit the information in the prescribed Form-A for merchant importers and Form-B for indigenous manufacturers or stockists duly signed by the authorised person and to be submitted before March 3, 2020 along with soft copy in excel format at email@example.com or firstname.lastname@example.org.
NPPA has also urged all State Drug Controllers (SDCs) to ensure compliance of this order and an indicative list of importers has also been shared for ready reference.
Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Alliance (IPA), Organisation of Pharmaceuticals Producers of India (OPPI), Bulk Drug Manufacturers Association (BDMA), Federation of Indian Chambers of Commerce and Industry (FICCI), Confederation of Indian Industry (CII) and Federation of Pharma Entrepreneurs (FOPE) has also been asked to disseminate information related to it and also ensure compliance of this order.
Name of the APIs of which data is sought includes:
Amoxicillin, cephalexin, cefixime, cefoperazone, sulbactam, cefriaxone sodium sterile, potassium clavulanate, piperacillin+ tazobactam(8: 1), tetracycline, oxytetracycline,
Doxycycline, gentamicin, neomycin, streptomycin sulphate (sterile), meropenem, levofloxacin, azithromycin, sulfadiazine, clindamycin hydrochloride, clindamycin phosphate,
Ciprofloxacin, ofloxacin, norfloxacin, clarithromycin, chloramphenicol, metformin, metronidazole, tinidazole, ornidazole, artesunate, telmisartan, losartan, valsartan,
Omesartan, atorvastatin, vitamin B12, vitamin B1, vitamin B6, vitamin C, prednisolone, betamethasone (base), dexamethasone (BASE), progesterone, rifampicin, acyclovir,
Lopinavir, ritonavir, gabapentin, oxcarbazepine, carbamazepine, heparin, levodopa, carbidopa, aspirin, paracetamol, diclofenac sodium, erythromycin stearate/estolate and levetiracetam.