India: Pharmaceutical Update

Last Updated: 22 August 2016
Article by Trilegal .


Government Taking Steps to Set Up Funds to Promote Pharma Sector

The Department of Pharmaceuticals (DoP) is formulating a Pharmaceutical Technology Upgradation Assistance Scheme to support the pharma industry (medium enterprises only) "to upgrade their regulatory technology compliance from Schedule M of the Drugs and Cosmetics Act, 1940 to World Health Organization (WHO) - Good Manufacturing Practices (GMP) norms by facilitating low interest loans". The Government of India is also considering providing INR 2,000,000,000 (Indian Rupees Two Billion) each to 3 new bulk drug manufacturing parks in order to create common minimum facilities.

ISRO Carries Out Successful Testing of RLV-TD

Indian Space Research Organisation (ISRO) successfully concluded its first step towards testing India's first ever indigenous space shuttle Reusable Launch Vehicle Technology Demonstrator (RLV-TD).  While this test was the hypersonic flight experiment, the next test will be focused on landing the RLV-TD back on earth.

Patent Systems Should Be Country-Specific Favouring National Interest: India at WIPO

Despite pressure on the country to amend its patent laws to enable more patent protection, the Indian delegation, in the opening statement at the 24th session of World Intellectual Property Organisation (WIPO)'s Standing Committee on the Law of Patents (SCP) in Geneva, has suggested a country-specific patent system that favours the interest of the national economy.  On the issue of patents' quality, including patent opposition systems, the Indian delegation stated that the quality of examination needs to improve substantially in conformity with the policy objective of a country.

BREXIT to Majorly Impact Drug and Medical Device Regulation: Global Data Report

The Brexit is expected to have consequences for the pharmaceutical and medical device industries in 5 key areas, namely: regulatory impacts, research and development, access to talent, intellectual property rights and market access. There are other ramifications of Brexit for the healthcare sector. For instance, European Medicines Agency (EMA), which is headquartered in the UK, is likely to be swiftly relocated to the European Union.

World Bank to India: Activate Stalled Growth Engine

According to the World Bank, India needs to activate "stalled engines" - agricultural growth and rural demand; trade; and private investment, while ensuring that demand from urban households and public investments do not run out of fuel, to sustain 7.6% growth rate in the coming years.

Note: Since this update only covers issues and events till 31 July 2016 we have not included an update on the Goods and Services Tax (GST) Bill here. This will be covered in our next update.


Basic Economic Data:

GDP Growth (2015-16) (Jan-March): 7.9%
(CPI) Inflation (June, 2016):  5.40 % (Rural & Urban combined)
Foreign Exchange:  INR   66.7407 for 1 USD.
Unemployment Rate (2013-14): 4.9%


Union Cabinet Approves IPR Policy

The Union Cabinet of India recently approved the National Intellectual Property Rights (IPR) Policy (IPR Policy).

IN-DEPTH: The key objectives of the IPR Policy are:

(a)  to create public awareness about the economic, social and cultural benefits of IPRs among all sections of society;
(b)  to stimulate the generation of IPRs;
(c)  to have strong and effective IPR laws which balance the interests of rights owners with larger public interest;
(d)  to modernize and strengthen service-oriented IPR administration;

(e) to get value for IPRs through commercialization;
(f) to strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements; and
(g) to strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs.

FSSAI Establishes Central Advisory Committee

Food Safety and Standards Authority of India (FSSAI) has established the Central Advisory Committee under the Food Safety and Standards Act, 2006.
IN-DEPTH: The committee consists of the Mr. Pawan Agarwal (CEO, FSSAI) as the chairman, members of the food industry, consumers, Commissioners of Food Safety of States and Chairperson of the Scientific Committee.

NPPA Fixes/Revises Ceiling Price of Scheduled Drugs and Retail Price of Specified Formulations

The National Pharmaceutical Pricing Authority (NPPA), by its orders has fixed/revised the ceiling price and retail price in relation to specified formulations.
IN-DEPTH:  By these orders, the ceiling price in relation to 225 scheduled formulations have been notified, retail price of 74 formulations have been fixed and ceiling price of 15 formulations have been revised by the NPPA.

NPPA Issues Office Memorandums in Relation to Implementation of Drug Prices Fixed Under DPCO, 2013

The NPPA has issued office memorandums regarding: (a) Implementation of prices fixed under the provisions of Drug Price Control Orders (DPCO), 2013, (b) Representations against ceiling prices fixed by NPPA under DPCO, 2013, (c) Price fixation of I.V. Fluids under DPCO, 2013, (d) National List of Essential Medicines, 2015 formulation under provisions of DPCO, 2013, and (e) representation of companies aggrieved by the NPPA's price fixation.
IN-DEPTH: The office memorandums contain directions and obligation for marketing/manufacturing companies wherever relevant.

SUGAM Portal Rolled-Out for Additional Compliances

The online portal 'SUGAM' launched by the Central Drugs Standard Control Organization (CDSCO) has been rolled-out for additional compliances to be made by manufacturing companies.  Following the introduction of the online system, the south zonal office of the CDSCO in Chennai has kicked off the online issuance of licences and approvals.

IN-DEPTH: The SUGAM portal can now be accessed for: (a) filing application for grant of licence to import drugs for examination, tests or analysis, and (b) filing applications for grant of registrations of cosmetics and ethics committee.

FSSAI Issues Notices For Stakeholder Comments

The FSSAI has issued notices calling for suggestions, views, comments etc. from stakeholders in relation to certain specific regulations.
IN-DEPTH: The notifications relate to: (a) Standards for Fortified Atta, Fortified Maida, Durum Wheat Maida, Quinoa, Fortified Rice, Instant Noodles, Tapioca Sago or Palm Sago & Pearl Millet Flour, (b) "Fruit & Vegetable products" in Regulation 2.3 in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011, (c) Table 4 in Appendix B in Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, and (d) Fats, Oils and Fat Emulsions in Regulation 2.2 of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.  The comments are to be shared within the timelines specified in each of these notifications.

FSSAI Releases Draft Amendment Regulations under Food Safety and Standards Act, 2006

The FSSAI, has released drafts of certain specified amendment regulations.
IN-DEPTH: The amendment regulations include: (a) Food Safety and Standards Authority of India (Transaction of Business and Procedures for the Scientific Committee and Scientific Panels) Regulations, 2016, (b) Food Safety and Standards (Prohibition and Restriction on Sales) Amendment Regulations, 2016,  (c) Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulations, 2016, (d) Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulation 2016, and (e)  Food Safety and Standards (Packaging and Labelling) Second Amendment Regulation, 2016.  These amendment regulations will be taken into consideration after the expiry of the time specified in each of the notifications for receiving objections and comments, if any, from the relevant stakeholders.

FSSAI Notifies Amendment Regulations under Food Safety and Standards Act, 2006

The FSSAI has notified certain specified amendment regulations.
IN-DEPTH:  The notifications relate to: (a) Food Safety and Standards (Licensing and Registration of Food Business) First Amendment Regulation, 2016, (b) Food Safety and Standards (Packaging and Labelling) Third Amendment Regulation, 2016, (c) Food Safety and Standards (Food Products Standards and Food Additives) Fourth Amendment Regulations, 2016, (d) Food Safety and Standards (Food Product Standards and Food Additives) Fifth Amendment Regulation, 2016, (e) Food Safety and Standards (Food Product Standards and Food Additives) Third Amendment Regulation, 2016, (f) Food Safety and Standards (Packaging and Labelling) Second Amendment Regulation, 2016, (g) Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2016, (h) Food Safety and Standards (Food Product Standards and Food Additives) Second Amendment Regulation, 2016, (i) Food Safety and Standards (Packaging and Labelling) First Amendment Regulation, 2016, (j) Corrigenda for Food Safety and Standards (Contaminants, toxin and residues) Amendment Regulation, 2016.

Revision of FSSAI Testing Charges

FSSAI has reconsidered the analysis charges for different food products and decided to introduce package rates for food testing for ease of operation and integration of single window system of imports.
IN-DEPTH: These package rates shall be uniformly applicable for both domestic and import samples.

FSSAI Operationalises List of Food Additives

FSSAI operationalised the final list of 11,000 food additives provisions that can be used by food businesses in various food categories.
IN-DEPTH:  This culminates an important process in developing food standards for food additives that began about 3 years ago.
Direction on Application of Food and Safety Standards Act and Regulations Thereunder to Duty Free Shops
FSSAI has issued a direction clarifying that duty free shops would be outside the ambit of Food Safety and Standards Act, 2006 and Regulations made thereunder.
IN-DEPTH: Accordingly, clause 14.3 of the notice for operationalization of the Food Safety and Standards (Food Import) Regulations 2016, which stipulated that the act and the regulations would be applicable to all duty free shops in all airports of India stands deleted till such time the above regulations are notified.

ICMR Lays Down New Rules for Clinical Trials and Consent, Applies Them to Traditional Medicine

The Indian Council for Medical Research (ICMR) has recently released draft National Ethical Guidelines for Biomedical and Health Research involving Human Participants which lays down the rules on informed consent of people participating in trials.
IN-DEPTH: The draft clarifies what informed consent will mean: one where participants are provided all relevant information, comprehend the nature of that information, and their consent is voluntary.  It also provides that payments be made as reimbursements for travel, etc., or for wages lost, but never as "undue inducement".

Amendments to India's FDI Policy on the Pharma Sector

In a major overhaul, the government has relaxed foreign direct investment (FDI) norms in various sectors, including the pharmaceutical sector.
IN-DEPTH: With the objective of promoting the development of this sector, the government has permitted up to 74% FDI under automatic route in brownfield pharmaceuticals and government approval route beyond 74% will continue.


5 Web Portals Under FDA Scanner for Selling Drugs Online

5 web portals have come under the radar of the Food and Drug Administration (FDA) for selling prescription drugs online.While the FDA has already registered First Information Reports (FIRs) against 3 web portals, the process of initiating action against the other 2 is under way. 

IN-DEPTH: Web portals (a), (b)  Web portals (a), (b), (c)  Web portals (a), (b), (c), (d)  Web portals (a), (b), (c), (d), and (e)  Web portals (a), (b), (c), (d), and (e) were found selling drugs, available over the counter and scheduled drugs, through an online system.  While action has been initiated against each of these portals, the FDA is also looking to take action against pharmacies that are supplying drugs to these web portals.

Reckitt Benckiser Given Due Hearing on Condom Order

Delhi High Court disposed of the plea filed by Reckitt Benckiser, challenging the State licensing authority's order directing the company's Indian joint venture firm TTK Protective Devices Limited (TTK) to surrender its licence for manufacturing and selling Benzocaine dosed condoms. (W.P.(C) 4442/2016 disposed of on 23 May, order accessible at
IN-DEPTH:  The order put on hold the orders of the Centre and State licensing authority directing TTK to surrender its licence for manufacture and sale of Benzocaine dosed condoms.  The Delhi High Court has now directed TTK, to file its representation within two weeks and to maintain a "log and accounts" of the number of such condoms manufactured and sold by it.

INR 2,500 Crore Drug Bust: Pharma Companies Under Scanner

The Thane crime branch busted an international drug cartel and seized narcotics worth around INR 2,500 crore leading to increased scrutiny on pharmaceutical companies at Maharashtra Industrial Development Corporation (MIDC).
IN-DEPTH: The police caught the racket run by Avon Lifesciences Limited and arrested eight people.  This event has alerted the Food and Drugs Administration which is now conducting surprise inspections on pharmaceutical companies.

Supreme Court Directs Cipla to Pay INR 175.07 Crore

The Supreme Court of India had directed drug maker Cipla to deposit a sum of Rs 175.07 crore in a case related to alleged overcharging in certain drugs as per the provisions of Drug (Price Control) Order, 1995.  In a note to stock exchanges on 22 July, Cipla said the writ petitions filed in the Bombay High Court that were pending before the Supreme Court have been retransferred to the Bombay High Court for final hearing.  The initial order for the deposits were issued by Supreme Court in 2003, which had directed the government to recover 50% of the overcharged amount by the company.


Pharma Exports Growth Heading for a Sharp Decline

The Credit Rating and Information Services of India Limited (CRISIL) has issued a report stating that the Indian pharmaceutical sector is heading for a tough time as exports growth in formulations is expected to almost halve to 10-12% annually over the next 5 years.
IN-DEPTH: Domestic companies will have to step up investments in new molecules and draw up a roadmap to deal with lower generics growth in order for growth to sustain beyond 2020.

WHO Unveils Global Regulatory Framework for Medical Devices

The WHO has released a draft proposal for its global regulatory framework for medical devices and In Vitro Diagnostics (IVDs).
IN-DEPTH: The WHO framework provides guidance for a staged development.  Public comments on the draft proposal were also invited.

Government Looking to Amend Drugs and Cosmetics Act

The Central Government of India is working towards amending the Drugs and Cosmetics Act, 1940 as the existing legislation does not differentiate between offline and online pharmacies.
IN-DEPTH: Additional Secretary in the Ministry of Health & Family Welfare, Mr. K B Aggarwal said, though e-pharmacy will allow easy availability of drugs at all hours, certain concerns with respect to legitimacy of e-pharmacies, patients' safety and privacy, misuse of e-pharmacy and adverse effect on retailers business should be flagged and addressed.


Workshop on 'Building Consumer Awareness on Improving Accessibility to Medicines"
on 18-19 August 2016 at Delhi, in association with Consumer Online Foundation
Seminar on "BioPharma: Biosimilar & Biogeneric; Emerging Investment Destination"
on 6 October 2016 at Hyderabad, in association with ASSOCHAM

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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