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KEY FEATURES OF THE RIGHTS OF PERSONS WITH DISABILITIES ACT, 2016

        KEY FEATURES OF THE RIGHTS OF PERSONS WITH DISABILITIES ACT, 2016 Applicability of RPwD Act, 2016 The RPwD Act, 2016 applies to both government establishments and private establishments. The term “establishment” includes government establishments, which are corporations established under Central or State Acts, authorities or bodies owned, controlled, or aided by […]

E SHOP SHIPING CHARGE ON SALE OF DRUGS

      Currently, Delivery Charge is shown as “E SHOP SHIPING CHARGE” and is covered under HSN Code — 30049099 — this HSN code is reserved for Pharma products. Is current implementation legal? Whether they are shipping non-pharma products under the same HSN. Further, since HSN code 30049099 is only applicable for “pharma products”, […]

Track & Trace for Pharmaceutical Products compliance

            Track & Trace for Pharmaceutical Products compliance Background: Following the recommendation of the drugs technical advisory board, the national drug regulatory body is getting ready to introduce a tracking mechanism and has identified 300 top brands for the purpose on the basis of moving annual total data. The plan, […]

REPACKING OF DRUGS

            REPACKING OF DRUGS Important Laws Drugs and Cosmetics Rules, 1945 Drugs and Cosmetics Act, 1940 Repacking of Drugs – Allowed (After Obtaining a license). Drugs – Repacking can be done only for which the license is granted. Repacking will fall under the category of manufacturing – Section 3 (f) […]

QR CODE AND ANTI-COUNTERFEIT MEASURES

    Applicable Laws on QR Code: The Ministry of Health and Family Welfare, on 14 June 2022, issued a notification vide G.S.R. 448(E) amending a certain rule in the Drugs Rules 1945, for mandating Barcode or Quick Response (QR) code on the label of top 300 brands of drugs from May 1, 2023. The […]

Don’t Miss the Bus – EBA Guidelines and compulsory implementation

      Don’t Miss the Bus – EBA Guidelines and compulsory implementation. Banking companies and financial institutions have five months before the deadline to bring legacy outsourcing arrangements into compliance with the European Banking Authority “Guidelines on outsourcing arrangements” (“EBA “). In this article, we set out the background and applicability of EBA for […]

Uniform Code for Medical Device Marketing Practices

The Medical Device sector in India is an essential and integral constituent of the Indian healthcare sector particularly for the prevention diagnosis treatment and management of medical conditions, diseases, illnesses, and disabilities.  it forms an important pillar in the healthcare industry system along with healthcare providers pharmaceuticals and health insurance industry thereby helping achieve the […]

REGULATION OF SCHEDULE K DRUGS IN INDIA

Introduction: The Union Government, vide GSR no 393 (E) dated May 25, 2022, for the first time, proposed to introduce over-the-counter (OTC) drugs in India through an amendment in the Drugs and Cosmetics Rules, 1945 (D&C Rules) to allow their sale in the retail market without the prescription of a Registered Medical Professional (RMP).[1] To […]

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