20 June 2018

India’s aspiration to become the clinical trials hub is under threat

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India’s aspiration to be a fast-growing, low-cost hub for clinical trials is under threat because of the slow government approval given to test new medicines. Hence, some of the drug firms in India are shifting their operations to some other location, because of which high cost is incurred to the country, according to the report given by Reuters.

In India, drugs firms are complaining that there is a regulatory uncertainty in the market which is mainly created due to lack of legal clarity on how to conduct clinical trials and sluggish bureaucracy in New Delhi.

In the Supreme Court, this has become a high profile case between the health activists and the regulator, who are complaining that the drug firms are using poor people to conduct clinical trials of unsafe drugs, without proper state scrutiny and consent. Hence, they have appealed to the court to stop all the new chemical entities trials i.e. NCE’s substances that will become a new drug after the tests are conducted.

Because of the ongoing case in the Supreme Court between drug regulatory body of Indian government and the drug firms, Piramal Enterprises Ltd, which is a $1.8 billion Indian drug maker was forced to shifted their operations to abroad so that new drugs would be tested, according to Swati Piramal, the vice-chairperson of Piramal Enterprises Ltd. She also said that, currently in India for the approval of drug trials it would take around 6-8 months, whereas in Europe and Canada, to get a drug trial approval it takes only 28 days.

Ranbaxy, Cipla, Dr. Reddy’s Laboratories, Lupin, Aurobindo Pharma, Sun Pharmaceutical, Cadila Pharmaceuticals, Jubilant Life Sciences and Surya Pharma are some of the top pharmaceutical companies of India.

Last year, Lupin Ltd, which is the fourth-largest drug maker by sales in India, wanted to conduct an NCE trial in country, but because of the slow approval process of the Supreme Court, forced the $5 billion firm to get their clinical drug trials to be conducted overseas.

In 2011, the domestic drugs trial market was around $485 million worth, but by 2016 it is forecast to double and rise to $1 billion, according to the report given by Frost & Sullivan.

India was an important destination for companies to carry out clinical trials mainly driven by the country’s low cost of conducting trials and a fast-growing population of 1.2 billion. In the field of generic drug-making, India’s exports to Latin America and Africa have made them as the biggest developing pharmacy in the word. But, because of the slow approval process for clinical trials, has made the Asia’s third-largest economy in becoming a testing hub for clinical trials. Currently only around 1.5 percent of global trials are taking place in India, which is very less, according to the report given by the Indian Society for Clinical Research (ISCR).

Global drug makers are changing their hub for clinical trials from India to Russia and Brazil, since the Indian government is delaying in giving approval to their trials. The cost incurred for drug trials in U.S is $20,000 which is 10-20 times more than India, according to Deepak Malik, a healthcare analyst at Emkay Global and the report given by ECCRO, a contract research organization.

Source: deccanherald.com

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