Monthly Archives: August 2014

Indian Supreme Court Asks Centre And ICMR To Produce Documents Granting Licences To Merck Sharpe And GlaxoSmithKline

Indian Supreme Court Asks Centre And ICMR To Produce Documents Granting Licences To Merck Sharpe And GlaxoSmithKlineHealthcare industry of India is witnessing many ups and downs. Indian government and pharmaceutical companies are trying their level best to mange healthcare related issues in India but there are more shortcomings than achievements till now.  For instance, health, food and medicine related legal compliances in India are not followed by various healthcare stakeholders. Similarly, dietary and health supplement, functional food and nutraceutical legal and regulatory compliances in India are also missing.

One area of great concern is the clinical trail of new drugs and pharmaceuticals in India that is not done in strict and legal manner. The Supreme Court of India has even asked Indian government to monitor and regulate all clinical trials of experimental drugs in India.

Clinical establishments operating in India are required to comply with the requirements of the Clinical Establishments (Registration and Regulation) Act 2010 (PDF) and the Clinical Establishments (Central Government) Rules 2012 (PDF). Further, Recommendations on Electronic Medical Records Standards in India (PDF) have also been prescribed that have to be followed and complied with by Indian clinics and healthcare professionals of India. An e-health authority of India is also in pipeline to implement electronic health record (EHR) standards in India and managing other related aspects.

Similarly, areas of e-health, m-health, telemedicine, etc can be undertaken only subject to techno legal compliances. Presently the healthcare industry and healthcare entrepreneurs of India are acting more on the side of violation than compliances. Even the m-health service providers in India are violating Indian laws. The Competition Commission of India (CCI) may also examine patent settlements that are being negotiated between foreign brand-name drug makers and domestic generic companies.

In a related legal development, the Supreme Court on Tuesday asked the Centre and Indian Council of Medical Research (ICMR) to produce files relating to grant of licences to pharmaceutical companies Merck Sharpe and GlaxoSmithKline. These licences allowed Merck Sharpe and GlaxoSmithKline to conduct clinical trials of two vaccines upon minor girls that is claimed to be capable of preventing cervical cancer.

Supreme Court has been hearing a Public Interest Litigation (PIL) to quash licensing of two vaccines for cervical cancer treatment on the ground that approval for their use was done without adequate research on safety.  It has been alleged that the Drugs Controller issued licences for the vaccines without adequate research on safety as directed by the parliamentary standing committee on health.  The Centre has also been asked to place before the Supreme Court the report of the House panel which had criticised the manner in which the vaccines were introduced in India. It also wants to know what action the government has taken subsequent to the report placed before Parliament in August last year.

CCI May Scrutinise Patent Settlements Between International Drugs Manufacturers And Indian Generic Drugs Producers

CCI May Scrutinise Patent Settlements Between International Drugs Manufacturers And Indian Generic Drugs ProducersThe corporate compliance requirements have drastically changed after the introduction of Indian Companies Act, 2013. Similarly, regulatory framework pertaining to companies operating in India has also been changed. For instance, foreign companies and e-commerce portals would be required to register in India and comply with Indian laws as per changed regulations applicable in India.

Drugs and pharmaceutical industry of India is also witnessing the impact of changed regulatory environment both in Indian market and foreign markets. The generic pharmaceutical companies of India are also passing through tough phase. However, the generic drugs industry of India is also giving sleepless nights to foreign pharmaceutical companies who are finding it difficult to compete with the economies of generics drugs.

As a truce, international drug manufacturers are entering into negotiations and settlements with the generic drug manufactures across the world, including India. However, not all settlements are genuine and in many cases these settlements are unreasonable means to stifle domestic competition that results in higher prices for the drugs in the concerned country.  This is clearly an unfair practice and anti competition and anti trade in nature.

It has been reported that the Competition Commission of India (CCI) may examine patent settlements that are being negotiated between foreign brand-name drug makers and domestic generic companies. In these arrangements, a brand-name drug maker reaches a settlement with a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. Many have raised the concerns that such deals would restrict access to affordable medicines in India.

CCI is scrutinising the deals between Tarceva lung cancer drug made by Roche and a deal with Cipla and the settlement between Glenmark Pharmaceuticals and Merck concerning the Januvia diabetes pill. In Federal Trade Commission v. Actavis, inc., Et Al. No. 12–416. 570 U. S. (2013) (PDF) the U.S. Supreme Court adjudicated upon a similar complaint of the U.S. Federal Trade Commission (FTC).

CCI also plans to probe the market impact of injunctions that were obtained over the past year by Novartis and Merck against a dozen domestic drug makers, which were prevented from selling copies of diabetes drugs.