August 13,2024
In less than a week since the Drugs Controller General of India (DCGI) has given permission to pharma companies to launch certain types of drugs without local clinical trials, the economic think tank GTRI (Global Trade Research Initiative) has opposed the decision.
GTRI has said that the decision is going to adversely impact the patients in India and could hurt the domestic pharma industry. “By overlooking India’s unique genetic diversity, the waiver could lead to unexpected safety and effectiveness issues. Also, it might increase competition from multinational corporations making it harder for local pharma companies and contract research organisations (CROs) to grow,” GTRI said in a statement.
As per the think tank, the genetic make-up of Indians are different from the US and EU who have diverse population, and therefore, it’s essential to do local trials to ensure that new drugs are both safe and effective for Indian patients.
The DGCI has exempted the local clinical trials across five categories of new drugs, including drugs for rare diseases, gene and cell therapies, pandemic-related treatments, and those with significant therapeutic advances. GTRI said that many of these drugs are developed quickly, and are experimental. “Some companies get approval abroad but choose not to sell these drugs there due to concerns about patent protection and potential compensation if something goes wrong. Instead, they focus on countries with weaker regulations like India. We must exercise caution as many such drugs can lead to serious and sometimes dangerous outcomes,” GTRI said.
Meanwhile, pharma association said that even though the companies are not required to do phase 3 trials now, they will still have to conduct post-marketing surveillance studies across thousands of patients. “While phase 3 trials are no longer required for certain new drugs, the companies will still have to conduct phase 4 studies which happens after the product launches,” said Anil Matai, director general, Organisation of Pharmaceutical Producers of India (OPPI).
Further, GTRI said that the waiver could affect local firms and CROs at the cost of MNC pharma companies.
“The reduction in the number of clinical trials could hinder the growth of over 250 local CROs. MNCs have argued that clinical trials in India were too expensive even though they cost much less than in the US. This (waiver) benefits MNCs by reducing costs and time, allowing them to launch new drugs faster. They also avoid the risk of compensation and liability if something goes wrong during trials,” said GTRI.
Source: Financial Express