India flooded with copycat versions of patented cancer drugs from Bangladesh

Laxmi Yadav, MumbaiFriday, February 15, 2019, 08:00 Hrs  [IST]

With most patented drugs are outside Drugs Price Control Order (DPCO), cancer patients in India have found a dubious way to procure them from Bangladesh. The copycat versions of patented drugs are being supplied to Indian importers from Bangladesh by abusing Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007.

The Rules which came into force on May 8, 2007 say no action can be taken against goods of non-commercial nature contained in personal baggage or sent in small consignments intended for personal use of the importer. These Rules are administered by the customs authorities of India.

However, the Rules say customs authorities may suspend the clearance of goods based on the notice given by a patent holder and have reason to believe that the imported goods are goods infringing intellectual property rights. They may suspend the clearance of goods on their own if they have prima facie evidence or have reasonable grounds to believe that the imported goods are infringing intellectual property rights.

Taking advantage of the Rules, certain suppliers get manufactured copycat version of patented drugs in Bangladesh which falls under least developed countries (LDCs) enjoys Agreement on Trade-Related Aspects of International Property Rights (TRIPS) waiver allowing LDCs to produce patented drugs without first asking patent holders until 2033. They import the copycat version of patented drugs in India under personal consumption category avoiding customs authority's scrutiny and sell them through illegal channels.

As per Drugs and Cosmetics Act, any drugs which are not licensed by DCGI in India cannot be sold in the country. The copycat versions of patented drugs are not licensed in India and are brought to the country illegally as a personal shipment and are also sold illegally. There is no track of it, said a patent expert on condition of anonymity.

The Indian pharmaceutical industry being one of the largest, ranked fourth in the world in respect to the production volume, cannot produce patented drugs since the country signed TRIPS pact in 2005 which allows product patent.

Before the arrival of the patent regime in 2005, it was easier for Indian drug makers to imitate the drugs discovered by MNCs at a much low price but since the new regime, the Indian companies have to rethink and invest more on research & development.

There are more than a dozen drugs which are crucial for cancer treatment are unavailable in India. New cancer medicines such as Dasatinib are already being generically produced by Bangladesh, even as Indian companies like Natco Pharma have had to withdraw such medicines from the Indian market because of patent rules.

Bayer's Stivarga which is used to treat some types of colorectal cancer is currently not approved in India.

The launch of these products depends on a number of factors, including market potential and the time taken for approvals in the country. It takes anywhere from four months to two years for a new product to enter India.

On other hand, a significant number of cancer patients belonging to low income category is not able to afford the newly launched cancer drugs by MNCs. Roche had launched late-stage breast cancer drugs-- Kadcyla and Perjeta in India in October, pricing Rs.2,10,000 (200 ml) and Rs.2,49,000 for a dosage, respectively. University of California, Los Angeles (UCLA) went on to pursue a patent on prostate cancer drug Xtandi in India, which would prevent generic drug makers from producing and marketing enzalutamide at a cheaper rate.

Drug companies in Bangladesh-- Beacon Pharmaceuticals, Incepta have emerged as panacea for such patients which produce patented drugs at much cheaper price.

A supplier on condition of anonymity said “We sell Osimertinib drug (Tagrisso) from AstraZeneca at Rs.1.1 lakh for 30 tablets. We also sell Tagrix brand of Osimertinib manufactured by a Bangladesh based Beacon Pharma at Rs.39,600. Another Bangladeshi firm Incepta Pharma’s Oscient is being sold for Rs.19,000.”