On 20 March, the department of biotechnology, under the union ministry of science and technology, in consultation with the Drugs Controller General of India—the body 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 a lot of 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—which has already been approved for the treatment of other diseases—as a “new drug” and 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 and the Drugs and Cosmetics Rules, 1945 or Drugs Rules, and administered by the DCGI. The Drugs Act and Drugs Rules make up a comprehensive regime for the regulation of the manufacturing, testing, approval, sale, stocking and marketing of pharmaceutical drugs, homeopathic, ayurvedic, unani medicines, and cosmetic products.
Governed by Schedule Y of the Drugs Rules, the tests are conducted in three major stages. “Product Characterisation,” the first stage, is aimed to clarify 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 such asrodent—rats—and non-rodent—rabbits to monkeys—populations, depending on the nature of the test, the nature of the drug, and the nature of the disease that the drug is intended for.
The pre-clinical trials are done in two steps. The first, pharmacology, deals with the working and affectability of the drug. These tests attempt to understand the drug’s movements through the subject’s body and how it is metabolised, absorbed, excreted and so on. The second step, toxicology, is the safety leg of animal testing and provides a glimpse on whether the drug is safe to use; whether it has any allergenic, carcinogenic or mutagenic properties; and its side effects.