Madras HC voices concern over India's heavy dependence on China for import of basic medicinal ingredients

Justice N Kirubakaran of the Madras High Court recently voiced concern over India's near total dependence on "enemy country" China when it comes to the import of ingredients for life-saving medicines (Vinkem Labs Ltd. v. Union of India and ors.).The Judge was hearing a batch of pleas moved by Chennai-based Vinkem Labs raising grievance over the lack of financial support from various banks. .Questions regarding whether the company, which is also involved in the research, development and manufacturing of cancer medicines, has enough potential to merit further funding were raised during the course of the High Court litigation. The case also saw the Court directing inspections to the company premises, including one by Amicus Curiae NL Rajah, who submitted a report on the same to the Court. .Pertinently, the overarching concern that grew out of the case became whether India is sufficiently self-reliant when it came to the production of medicines. On this count, recent border tensions with China prompted Justice Kirubakaran to remark, ."India has emerged as a pioneer in pharmaceuticals. Yet, for the basic ingredients of medicine making, it is heavily dependent on imports from one single neighbour nation, viz., China. This dependency handicaps us in responding effectively to security and other breaches by the neighbour. It also makes our patients to more often contend with spurious and sub-standard drugs and placing them in a vulnerable prospect of going without medicines if tensions escalate between the two countries, especially after Galwan valley tussle."Madras High Court.The Judge explained that though India does not import the medicines as such, it imports the active ingredients of a medicine, known as "Active Pharmaceutical Ingredients" or Bulk Drugs. This is used to make finished dosages for domestic and export purposes. .He added that "gradually, on account of import of API requirements at cheap costs, our country has declined to a mere Formulations hub.".The Judge further remarked, ."India’s API segment, built over several decades, has given way for cheap import APIs, primarily from China who were able to sell their APIs at 1/4th of their corresponding manufacturing cost in India. As a result, our country that had once built 99.7% self-reliance in APIs went on to import over 90% of its API requirements from China. The economic advantage of importing APIs has led India to lose its scientific edge and self-reliance in APIs and India now thrives as a mere Finished Dosage Hub, that is, a country that imports its API requirements and bundles them into finished dosages. On account of this abdication of domestic segment, the patients of our country have to face issues such as proliferation of sub-standard drugs, unavailability of life saving drugs etc., At one stage, even the National Security Advisor (‘NSA’) has cautioned the Government of the danger to our national security on account of this excess import dependence from a single nation.".To reduce this API import dependency, the Central Government constituted a committee of experts under eminent scientist Dr.VM Katoch, which gave its recommendations in 2015. An Inter-Ministerial Task Force was also put together to address the issue. However, even the 2015 recommendations are yet to be implemented, the Court noted. .Justice Kirubakaran observed that India's reliance on a single nation for key medicinal ingredients poses grave concerns. "One would shudder at the prospect of patients, young and old, being deprived of access to life saving drugs, especially, primary medicines for ailments that call for timely intensive medication such as tuberculosis, AIDS, Cardiovascular diseases, Cancer and so on", he added..During the course of the case, the High Court also took note of the related plight of farmers cultivating the herb vinca rosea (pink periwinkle plant), from which vinca alkaloids are extracted and used to treat cancer..An Association of vinca rosea cultivators approached the Court to support Vinkem's plea for funding, stating that the farmers' livelihoods would also be aided if the cancer-medicine manufacturer is able to revive itself. .The Court was told that the area of vinca rosea cultivation had drastically shrunk, partly due to erosion of export markets. This, in turn, was attributed to countries like China developing their own cultivation of the herb, thereby also emerging as a competitor for the farmers. .The Court was told that the losses faced by vinca rosea cultivators would best be addressed by promoting domestic procurement support. .The Court was also informed that an expert committee has certified that Vinkem Labs is the only company in India having the know-how for the isolation of vinca alkaloids, which go into the making of primary medicines for the treatment of various types of cancer. .In this backdrop, and citing larger concerns of public health the High Court proceeded to issue directions so that Vinkem Labs Ltd. may become a global player. The Court said that this was intended to achieve twin goals of bringing in foreign exchange for the country and to ensure India's self-reliance when it comes to cancer drugs. .To aid this effort, the Court has also constituted a five-member committee comprising of members from the Union Ministry of Pharmaceuticals, the Union Finance Ministry, the Tamil Nadu Department of Pharmaceuticals, Banks and Senior Advocate NL Rajah (the amicus in the case before the High Court)..The Committee was to be formed in eight weeks' time, the Court added. Vinkem Labs was directed to appraise this Committee of its progress every six months. Further, the company may have more frequent interactions with the committee, based on exigencies..The Judge remarked that India is not investing enough on research. In the absence of support, researchers and experts were compelled to migrate to other countries that are more encouraging, he said. Therefore, on a parting note, the Court opined,."We have already lost very capable brains to other countries by brain drain... it is time to retain the experts/scientists like petitioner by giving required support, more importantly trained support.".Read the Judgment: