Globally, regulatory authorities have developed a keen interest in the pharmaceutical industry. Recent enforcement actions, including the cases of GlaxoSmithKline, Johnson & Johnson, Valeant Pharmaceuticals, Abbott Laboratories etc., have paved the way for regulatory agencies to dig deeper into the malpractices prevalent in the pharmaceutical industry.

Back in 2014, the total pharmaceutical revenues worldwide had exceeded one trillion U.S. dollars for the first time. Increased competition owing to the growing size of the industry has noticeably increased the complexities of operations, sales and marketing, which in turn have led to an alarming spike in malpractices by stakeholders involved at various levels in the industry.

With the growth of the pharmaceutical industry and the unavoidable by-products that result from it, the industry is currently faced with a number of schemes that have been tailored to manipulate and defraud enforcement agencies and the public at large. The present article aims to identify the most common ‘red flags’ and fraudulent schemes that plague the pharmaceutical industry in India. Sufficient awareness about these fraudulent schemes is essential to equip auditors with a more focused and effective audit plan.

Red Flags and Fraudulent Schemes

The Indian pharmaceutical industry is faced with a number of challenges from a compliance point of view. The most prevalent fraudulent schemes in the industry relate to year-end targets, sales returns, etc., which are used as a veil to effectuate concerns around channel stuffing, free of cost products, free samples, fraud.

Continue Reading Red Flags in a Pharmaceutical Audit

This blog piece is excerpted from a previously published article in the Express Pharma, April 16-30 Issue and addresses the patent jurisprudence and issues in the pharmaceutical industry in India.

Innovation is the root of success in the competitive world of today. Creativity manifests in new ideas and technologies. New technologies when adopted make life easy. This could not be more true than for the pharmaceutical industry. With the Indian pharmaceutical industry en route to becoming a major player in the global market by 2020, there is increased activity in terms of investments in research and development, access to world class healthcare at affordable rates for the public at large and a renewed focus on development in rural markets.

Though patent law in India has existed over the years, jurisprudence related to pharmaceutical patents is still developing. From granting product patents, to specifically identifying patentable subject matter and incorporation of provisions for compulsory licensing, the law has come a long way since its inception. A conscious effort has been made to ensure that our laws are Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant while supporting a larger initiative to ensure that life saving medicines are available at affordable prices (compulsory licensing, price control etc.).

Courts in India are getting increasingly sensitive to the complex and technical issues that form the pith and substance of complex pharmaceutical patent litigation. Patent litigation turns on opinion of experts and evidence, which are often absent at the preliminary stages of litigation especially the interim injunction stage. As such the practice of passing ex-parte interim injunctions has given way to a more rational and balanced approach, wherein questions of prima facie infringement, balance of convenience and irreparable injury of the parties are weighed, analysed and rationalised along with a larger public interest perspective. The Supreme Court has time and again insisted that patent matters should be handled on an expedited basis especially where issues of public health, access to life saving drugs and commercial interests are involved and that matters should expeditiously head to trial. Courts are thankfully paying heed to this. Times are changing.

Continue Reading Intellectual Property Rights: Building or Stumbling Blocks? – On The Right Track