New Delhi: In a move that reworks the drug exam process in India, the Ministry of Health has developed rules that puts them in half for new drugs and clinical testing. The aim of the proposal is to speed up the innovation in pharmaceuticals, provide patients with faster access to drugs and expand the Indian footprint in the global industry of clinical trials of $ 1.55 billion.
On Wednesday, the Ministry of Health stated on Wednesday that it is amending new rules for drugs and clinical evaluation 2019 to support easy business. Proposed changes The streamlining process of testing licenses and certain studies by replacing the old licensing system with a faster online notification system. This is expected to shorten the time processing times by half, from 90 to 45 days, she said.
“The proposed changes will reduce the number of licenses submitted by approximately 50%,” the ministry said. The proposal of the announcement was looking for public comments within 30 days.
The proposal of the rules of new drugs and clinical evaluation (amendment), 2025, seeks to rework the regulatory framework by reducing bureaucracy for pharmaceutical companies. The rules’ proposal requires a new, simplified notification system for companies that create or conduct new drugs. For many drugs, society will no longer have to go through a long approval process; They can start production after the online notification is sent and confirmed by the Central License Authority.
However, existing patient safety rules will remain under new standards, and this rapid process will not apply to certain categories of drugs considered high -risk, such as sex hormones, cytotoxic drugs and narcotics.
To support Indian pharmaceutical exports, the Ministry for certain drug studies proposed a fast online announcement system. This applies to studies of biological availability and bioequival, which are essential to demonstrate the effectiveness of the drug. Biological availability concerns how well the active part of the drug is absorbed by the body, while the bioequival compares two similar drugs to ensure that they have the same effect.
One of the proposed key changes allows companies to launch drugs on exports with a simple online announcement, provided the product has already been approved on the main international markets such as the US, the United Kingdom, the EU, Japan, Australia and Canada. These studies will be limited to a maximum of 48 healthy adult volunteers.
In India, after successful attempts, the company submits a new drug application for the Standard Central Drugs control organization. If approved, the drug will receive a license for sale.
The proposed changes were welcomed by leaders in the sector of pharmaceutics. They emphasize the commitment of the government to relax business and encouraging research and development, she said that Sheetal Arara, CEO of human Pharma Ltd. “This step will remove obstacles that have long slowed down the decisive development of drugs, which will lead to faster innovation for patients and better business conditions,” she said.
Nikkhil K. Masurkar, CEO of Encod Pharmaceuticals, said the proposal of the rules means a decisive step towards establishing India as a global pharmaceutical center. “The new online study announcement system already approved in other major markets will help to align the country’s practices with global standards, which will benefit both local and international partners. New rules are considered a clear sign of India’s commitment to regulatory perfection and patient -focused drugs,” Masurkar added.
It is believed that the Indian market with clinical assessment worth $ 1.55 billion in 2024 in 2024 will reach $ 3.34 by 2034, driven by cost efficiency and a large population of patients. According to Nova One advisor, the IMARC Group, the country is currently 8% of Global Clinical Trial. The US is a global leader in this industry, followed by the main markets in Europe and China.
(Tagstotranslate) Indian Health Industry (T) Encod Pharma (T) Pharma Pharma (T) Clinical Drag Ties in India
