Import of raw materials (active pharmaceutical ingredients, or APIs) from China was giving sleepless nights to domestic pharmaceutical companies. Nowadays, “illegal” import of drugs from Bangladesh and other neighboring countries have furtherincreased their worries. These has not only impacted revenues but, more significantly is posing a risk to patients.

Studies commenced by experts, and confirmed by companies, suggest a blooming ‘grey’ market of fake and unapproved copies of Big Pharma’s oncology and hepatology medicines, and some under patent protection. Since these medicines are trafficked, exact numbers are not available, but estimates suggest that this grey market might be over Rs 300 crore for only oncology drugs.According to oncologists, about 12% of those prescribed these medications could be consuming fake tablets/capsules,. The safety and efficacy of these capsules is unknown, as they are not imported through the legal route.

Also, these drugs have not undergone clinical trials, and do not have the drug controller’s approvals. It is understood that quasi-government bodies — like the Employees’ State Insurance Corporation (ESIC) and the Central Government Health Scheme (CGHS) — are unintentionally sourcing these products. Sources said that the Organisation of Pharmaceutical Producers of India (OPPI) have discussed the matter with the government. The member companies were guaranteed that certain steps would be taken soon.An expert saidthat a majority of these medicines have been manufactured by companies in Bangladesh and are made only for exports. It would benefit if the border is strengthened to prevent the illegal entry of these drugs.

Cancer drugs are not sold through retail chemists but by distributors unlike other drugs. It would be comparatively easier to trace those involved in this scam. MNCs had hit due to the flourishing grey market which includes Novartis, Janssen (J&J’s pharma arm), Astra Zeneca, Takeda and Eisai. Copies of drugs like osimertinib priced around Rs 2 lakh by Astra Zeneca, crizotinib by Pfizer with a price tag of over Rs 1 lakh, and ibrutinib by Janssen, priced at over Rs 4 lakh in the domestic market, are available at a fraction of the price.

A Janssen spokesperson said that whenever they are alerted to potential illegal imports, they work with related judicial authorities and law enforcement agencies to attempt to fightagainst such activity. A study in Indian Journal of Medical Sciences states that certain Bangladesh companies are deliberately targeting doctors and patients from across the border using WhatsApp, email, social media and, in certain cases, are also reaching out to patients through chemists located near cancer hospitals.

Purvish Parikh, an oncologist with Shal by Cancer and Research Institute, and the study’s co-author, said that the package boxes are of good quality and can attract even the educated in believing that its contents are also produced with care. But, the batch numbers and bar codes do not follow internationally accepted norms. When it is coupled with the fact that there is no evidence of any testing in humans, no drug authority/ regulatory approval, not marketed within Bangladesh itself, no official presence in India, there is a serious question on whether the package contains simply an inert powder or, still worse, chemicals of questionable quality which could be possiblylethal.

Eisai Pharma MD Sanjit Singh Lamba said that bar coding on medicine packs can prevent this. The government has announced bar coding for domestic sales which is voluntary right now. But have urged it to be made mandatory (on manufacturers). He further said that most associations like OPPI, IPA and IDMA favor a secure supply chain for pharma products.

Praveen Sikri, founder and CEO of Ikris Pharma Network, which connects patients with overseas suppliers also said that traders smuggle unapproved medicines and illegallysell it in India. Few counterfeits/fakes are available at 1/20th of the innovators’ products. There is a compromise on the expected treatment outcome whileusing such unapproved medicines.

Source: ET Healthworld