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The Operation of e-Pharmacies and Data Privacy Risks

E-Pharmacies and operations thereof have been a contentious issue for long. While the issue remains static largely due to the delay in the notification of the E-Pharmacy Rules that were drafted in 2018, there is significant litigation that has ensued as well. The Government is contemplating whether e-pharmacies should be allowed to sell medicines online and, in this vein, the Drugs Controller General of India (“DCGI”) has issued show-cause notices to over 20 e-pharmacies to give them an opportunity to explain their operations and compliance with the regulations. As litigation ensues and rival contentions are presented before the courts[1], the Indian Government is currently seeking proper legal opinion on the regulation of e-pharmacies.Continue Reading The Operation of e-Pharmacies and Data Privacy Risks

FVCI Regulations

Introduction

The Securities and Exchange Board of India (“SEBI”) has released a consultation paper[1] on May 18, 2023 suggesting changes to the regulatory framework for registration and eligibility of Foreign Venture Capital Investors (“FVCIs”). Public comments have been invited on the consultation paper.

SEBI’s proposals are broadly to align the conditions under the SEBI (Foreign Venture Capital Investor) Regulations, 2000 (“FVCI Regulations”) with certain conditions under the SEBI (Foreign Portfolio Investors) Regulations, 2019 (“FPI Regulations”), and with a view to ensure adequate due-diligence and regulate the inflow of foreign capital in India through the FVCI route.Continue Reading FVCI Regulations 2.0: SEBI Proposes to revise FVCI Registration and Eligibility Conditions

OTT Platforms

Over-the-Top curated content platforms (OTT/OTT platforms) have found their niche in India. From international platforms like Netflix, Amazon Prime Video and Disney-Hotstar to home-grown streaming platforms like JioCinema, ZEE5, Voot, SonyLiv, Aha and ShemarooMe, India is a key market for one and all.Continue Reading ‘Over-the-Top’ Interference with Curated Content in India

Aircraft Leasing in IFSC

In our previous post we had provided a synopsis of the legal framework relating to aircraft leasing in India and Indian IFSCs. In this piece, we will provide an overview of the tax incentives offered to the aircraft leasing activities undertaken from  IFSCs located in India to achieve the dream of developing the GIFT IFSC into a global aircraft leasing hub. We have provided  a few more thoughts to ponder upon as India fuels its engines to realise its objective of ‘letting the common citizen of the country fly’ (Ude Desh Ka Aam Nagrik).Continue Reading Part III (B): Aircraft Leasing in IFSC – Let’s kick the tires and light the fires!

IRDAI clarification Written Mandate under the IRDAI (Insurance Brokers) Regulations, 2018

The Insurance Regulatory and Development Authority of India (IRDAI) notified the IRDAI (Insurance Brokers) Regulations, 2018 (Brokers Regulations) on January 12, 2018, repealing the erstwhile brokers regulations of 2013. This continues what is now considered an eventful financial year for the insurance regulatory space in India.

The Brokers Regulations improved upon the existing framework for the governance and regulation of insurance brokers- who act as significant intermediaries in the insurance sector. IRDAI, under these new Regulations, prescribed that all insurance brokers are required to comply with the code of conduct (Code of Conduct) set out in Schedule I – Form H of the Regulations.
Continue Reading IRDAI Issues Clarification on Form of Written Mandate under the IRDAI (Insurance Brokers) Regulations, 2018

Online Pharmacy Regulations in India

The Indian Pharmaceutical industry is in its prime phase of growth today at 11-12% per year. While exports occupy a huge chunk, the country meets nearly 95% of its own domestic demands through indigenous production and the domestic retail market is growing by leaps and bounds.

Sale of drugs in India is currently governed by the Drugs and Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). At present, the law permits sale of drugs through brick-and-mortar pharmacies only. The law as it currently stands is somewhat out of tune with the times in that it is still to catch up with the concept of online sales of drugs.
Continue Reading Medicines in Your Mail: The India Regulatory Story