On 20 March, the department of biotechnology, under the union ministry of science and technology, in consultation with the Drugs Controller General of India, or DCGI—the authority responsible for approval of licenses of drugs and vaccines—issued an office memorandum, setting out timelines for faster approvals of applications for COVID-19 related vaccines and treatments. In the meantime, several companies have already joined the race to be the first to develop a COVID-19 drug and vaccine. For instance, the Indian pharmaceutical firm Cipla has tied up with the Hyderabad-based Indian Institute of Chemical Technology, to work on an antiviral drug for COVID-19. Meanwhile, many countries such as the United States have already begun clinical trials for potential drugs and vaccines.
At this stage, it is up to the governments to assist and regulate the companies to ensure that a drug or vaccine is developed as quickly as possible, and also ensure safety and effectiveness. The Indian drug law, however, does not provide clear guidance on how to move quickly to ensure the availability of a safe and effective treatment.
Any drug or vaccine to combat COVID-19 among Indians would have to be invented in India or imported once it has been developed abroad. In both scenarios, the testing pathway for the Indian authorities to approve a drug for sale in India is very similar. Notably, this pathway treats an existing drug that has already been approved for the treatment of other diseases as a “new drug.” This new drug therefore needs to be tested again to see if it can be repurposed for COVID-19, since no scientific data exists demonstrating the drug’s effectiveness on the new disease.
The regime for testing and approval of drugs and vaccines is governed by the Drugs and Cosmetics Act, 1940 or Drugs Act; the Drugs and Cosmetics Rules, 1945 or Drugs Rules; and the New Drugs and Clinical Trials Rules, 2019—all administered by the Drugs Controller, India or DCI. The DCI is a body of officers that the 2019 rules establish, which is headed by the DCGI. The Drugs Act, Drugs Rules and Clinical Trial Rules make up a comprehensive regime for the regulation of the manufacturing, testing, approval, sale, stocking and marketing of pharmaceutical drugs, homeopathic, ayurvedic and unani medicines, and cosmetic products in India.
Governed by the Second Schedule of the Clinical Trial Rules, tests for new drugs are conducted in three major stages. “Product Characterisation,” the first stage, is aimed at clarifying the nature of the drug, which involves determining the chemical composition of the active ingredient, its molecular weight, physical properties, solubility, acidity, basicity, dosage form, method and so on. The next stage—“Pre-Clinical Trials”—involves testing the drug on animal subjects, including rodents such rats and non-rodents such as rabbits and monkeys, depending on the nature of the test, the nature of the drug, and the nature of the disease that the drug is intended for.