Think tank flags concerns in rolling out drugs without clinical trials

Introducing drugs without local trial data could be risky, especially considering India’s unique genetic and environmental factors, think tank Global Trade Research Initiative (GTRI) has cautioned.

GTRI’s caution comes after the Drugs Controller General of India (DCGI) on 7 August allowed certain new drugs approved in countries such as the US, UK, Japan, and the European Union (EU) to be sold in India without local clinical trials.

“The waiver raises concerns about patient safety and the impact on the local pharmaceutical industry. By overlooking India’s unique genetic diversity, the waiver could lead to unexpected safety and effectiveness issues,” GTRI said.

The think tank also expressed apprehensions that the move may increase competition from multinational companies (MNCs), making it tough for local pharmaceutical firms and contract research organizations (CROs) to grow. CROs provide support to the pharma, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.

“The waiver is one sided, with India not getting reciprocal treatment in the beneficiary countries. It is a major victory for pharma MNCs, who will now push for other demands,” GTRI founder Ajay Srivastava said in the report.

The cost of drug clinical trials varies depending on the trial phase, the type of drug, and the location. A US pharma firm may spend between $40-80 million to complete clinical trials before launching a new drug in the US. In India, the costs are much lower, ranging from $8-20 million, the report pointed out.

Most major multinational pharma companies argue that clinical trials in India are too expensive, even though they cost less than in the US. They secured a waiver, allowing them to skip local trials in India, which reduces costs, time, and liability risks, facilitating faster drug launches and broader market access, the report said.

Despite advocating for this waiver, these companies also push for data exclusivity, which blocks Indian generics from using their trial data. This strategy delays generic drug market entry post-patent expiry, revealing a contradictory stance on the value of clinical trial data, the GRI report said.

The waiver neglects the importance of trials across India’s diverse regions—North, South, East, and West—to evaluate drug performance in various ethnic and genetic subgroups. This is vital because genetic diversity affects drug metabolism, effectiveness, and safety. Without local trials, drugs approved elsewhere might not work as expected in India, raising potential safety and efficacy concerns, Srivastava said in the report.

The waiver extends to new drugs for rare diseases, gene and cell therapies, pandemic-related treatments, and significant therapeutic advances. Many of these drugs are developed rapidly, are experimental, and not fully tested. Some companies, after obtaining approval abroad, opt not to market these drugs there due to patent concerns and potential liabilities, instead targeting countries with looser regulations like India. Caution is crucial as these drugs can pose serious risks, Srivastava said.

With international firms entering the Indian market more easily, local companies may face increased competition. Additionally, the reduction in the number of clinical trials conducted in India could hinder the growth of more than 250 local CROs and other stakeholders in the clinical trial industry, the GTRI report added.