India: Few Major Developments In Drugs And Pharmaceutical Industry

No NOC for Pharmaceutical Exports to Developed Countries: The Central Drugs Standard Control Organisation (CDSCO) has relaxed the drug regulatory clearance for the pharmaceutical exporters of India to developed countries through wide No.DCGI/MISC/2015 (199) dated on December 11, 2015. It has been decided that the requirement of 'no-objection certificates' with respect to Shipping Bills from the port offices of the CDSCO for the export consignments to USA, Canada, Japan, Australia and European Union shall not be insisted with effect from January 1, 2016. This is being done in pursuit to bring ease in the drug regulatory practices in India related to export of drugs, medical devices and cosmetics. All the stakeholders are however required to comply with the regulatory requirements of the importing countries as per their specific need.

Regulation of e-Pharmacies: Circular issued by the Drugs Controller General of India (DGCI) dated December 30, 2015 does not impose any ban on e-pharmacies but only seeking strict adherence to the Drugs and Cosmetics Act and Rules. Online players based act as aggregators of both organised and unorganised retailers and should fully comply with all the rules stated by the Drugs and Cosmetics Act and should not allow any fulfillment of requirements without a proper prescription. The Drugs and Cosmetic Rules, 1945, under which the circular has been issued, regulates the sale and distribution of drugs in the country and does not distinguish between conventional and over-the-Internet sale of drugs. In the recent past, a few trade bodies of offline pharmacies have filed complaints stating that online medical stores are violating provisions under the Act. In this regard, the All India Drugs Control Officer's Confederation (AIDCOC) has in its letter to the sub-committee on e-pharmacy, suggested few amendments in Drugs and Cosmetics Rules, 1945, which include a separate part under Drugs and Cosmetic Rules, 1945 be incorporated to recognize online pharmacy including market place; market places should be required to register with the state licensing authority in which such market place (web platform) is located; market place should be subject to separate set of conditions of registration certificate which should include requirement of appointing registered pharmacist, ensuring that orders for Schedule H, Schedule H1 and X drugs are forwarded to the licensed pharmacy only if it is supported by valid prescription.

Proposed Cap on Sale Margins: With regard to the probe on "astronomical" price mark-ups on generic medicines that drug makers sell through distributors, as ordered by the Prime Minister's Office, a senior official in the Department of Pharmaceuticals (DoP) informed in mid January that a committee set up last year under the DoP has proposed a cap of 35% to check irrational margins on medicines. This margin is the margin which wholesales and retailers earn by selling the medicines. A total of 680 medicines are under the National List of Essential Medicines ( NLEM) under the scheduled category of DPCO, 2013. The NPPA has already fixed the ceiling prices in respect of 530 medicines.

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