India Regulatory Brief: New Medical Device Regulations for 2015, GDP Growth Revised

India’s Medical Devices Regulations Set to Change in 2015

India’s health ministry has released a proposed draft of the Drugs and Cosmetics (Amendment) Bill. Set to be submitted to parliament for approval later this year, the new legislation would align India’s regulations with the European Medical Device Directives.

In addition to updated definitions, the new legislation would simplify import procedures and affect change across many areas including: manufacturing, sales, distribution and clinical trial of medical devices. Furthermore, a Medical Devices Technical Advisory Board would be established to manage any technical and administrative issues that may arise.

The draft has been publicly disclosed for comment by stakeholders from industry, government, and the general public.

RELATED: Investing in India’s Medical Devices Industry

GDP Growth Revised by Almost 50 Percent

India’s official GDP growth in the 2013-14 financial year has jumped from 4.7 percent to 6.9 percent after India’s main statistical body revised the formula it uses to measure economic output. The most significant change is a “base year” revision that shifts the reference year for measuring inflation adjusted growth from 2004-05 to 2011-12. This brings India more in line with global standards by measuring the economy at market prices and tracking consumer rather than wholesale inflation. Other changes include new data sources that add under-represented and informal sectors as well as smartphones and LED television sets to GDP. India growth for the 2012-13 financial year was also revised up from 4.7 percent to 5.1 percent

Some in the government have predicted that the change will help bring down the country’s fiscal deficit as a share of GDP. However, chief statistician T.C.A. Anant has said that the overall size of India’s economy hasn’t changed enough to shift the ratio significantly.

Online Pharmacies to see Stricter Regulations

Several state governments in India are investigating the illegal trade of prescription medication via online pharmacies with a view to tightening regulations. The existing regulations, in conjunction with the country’s rising e-commerce industry, have led to a dramatic increase in the number of online pharmacies. Consequently, dangerous prescription drugs are readily available in India, with more than 40,000 listings online.

The Maharashtra Food and Drug Administration (MFDA) have urged the central government to formulate policy regulating the operation of online pharmacies in India. Recent investigations by MFDA found more than 20 illegal online pharmacies operating in India. In addition, the MFDA has raided 27 online pharmacies located in Mumbai, Thane and Pune and seized drugs worth over US$300 thousand.

If properly regulated, the online pharmacy business could be of significant benefit to India. Any new regulations will likely entail new operating procedures for legitimate enterprises, and inspire similar legislation in other states.

RELATED: Is India’s E-Commerce Industry too Regulated for FDI?

RBI to Implement New Consumer Protection Standards

The Reserve Bank of India (RBI) will soon set up a portal for consumers to file complaints. The portal is part of the RBI’s process of framing comprehensive consumer protection regulations based on global accepted best practices and recommendations from the Financial sector Legislative Reforms Commission (FSLRC). If implemented, the new regulations will require regulators to ensure consumer protection, according to RBI Executive Director NS Vishwanathan.

Many of the regulations are aimed at non-banking financial companies (NBFC).The portal itself will have information from various regulators who are part of the state level coordination committee (SLCC), which is an inter-regulatory forum that coordinates various agencies regulating the NBFC sector. Once the complaints are put into the portal the SLCC is meant to look into them and take quicker action than before.

Establishing Your Sourcing Platform in India
In this issue of India Briefing, we highlight the advantages India possesses as a sourcing option and explore the choices available to foreign companies seeking to create a sourcing presence here. In addition, we examine the relevant procurement, procedural and tax duty concerns involved in sourcing from India, and conclude by investigating the importance of supplier due diligence – a process that, if not conducted correctly, can often prove the undoing of a sourcing venture.

Taking Advantage of India’s FDI Reforms
In this edition of India Briefing Magazine, we explore important amendments to India’s foreign investment policy and outline various options for business establishment, including the creation of wholly owned subsidiaries in sectors that permit 100 percent foreign direct investment. We additionally explore several taxes that apply to wholly owned subsidiary companies, and provide an outlook for what investors can expect to see in India this year.

Passage to India: Selling to India’s Consumer Market
In this issue of India Briefing Magazine, we outline the fundamentals of India’s import policies and procedures, as well as provide an introduction to the essentials of engaging in direct and indirect export, acquiring an Indian company, selling to the government and establishing a local presence in the form of a liaison office, branch office, or wholly owned subsidiary. We conclude by taking a closer look at the strategic potential of joint ventures.

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