India has traditionally relied on its generic industry and price-controlling mechanisms to increase the accessibility of drugs.
Last week, the Centre waived the requirement of clinical trials for five categories of drugs if they have been approved by regulators in the US, UK, Australia, Japan, Canada and the EU. The regulatory relaxation covers drugs that provide “significant therapeutic advances over the current standard care, gene and cellular therapy products, medicines used to treat rare diseases, therapies that become necessary during a pandemic, and drugs used for special defence purposes”. Currently, a drug launched in developed economies takes between three to 15 years before becoming available in the Indian market. The waiver could be the first step in enabling doctors in the country to deploy novel therapies for Alzheimer’s, advanced stages of cancer and autoimmune disorders. The global pharma majors will save on the costs of conducting local trials and incentivise them in passing on some of the benefits to Indian patients. However, more needs to be done to ensure that cutting-edge therapies become available in the country’s pharmacies without imposing a high financial burden on the seriously ill.
India has traditionally relied on its generic industry and price-controlling mechanisms to increase the accessibility of drugs. These measures have worked to an extent. However, restrictions on market mechanisms remain the major reason for state-of-the-art medical research — in gene therapy, for instance — remaining inaccessible to large sections of patients in the country. After relaxing the clinical trial requirement, the government should initiate conversations on how best to enhance ease of business and innovation — the goal should be to ensure availability without hurting patient interest. This could mean more creativity in framing healthcare safety nets — making Ayushman Bharat more expansive, for instance — or even state procurement of novel drugs for a fixed period.
The government believes that the latest regulatory relaxation will promote indigenous research by providing early access to patient data. The country’s growing burden of communicable diseases requires synergies between laboratories in the country and outside its shores. But here, too, the government will need to handhold industry. Drug discovery is a long-term commitment that involves high costs. A leader in developing out-of-patent drugs, the country has been lagging in developing new medicine molecules. Low investor interest in biotech seems to have made the ecosystem challenging for start-ups. Given the premium it attaches to healthcare and R&D, the government should find ways to make the domestic pharma industry competitive.
