Govt lodges complaint with censor board about movie on clinical trials
New Delhi: In an unprecedented move, the Union ministry of health and family welfare has lodged a complaint with the censor board, the Central Board of Film Certification (CBFC), about an unreleased movie centred around clinical trials of new drugs in the country.
In its complaint, the health ministry has alleged that the movie—Umeed—presents “distorted and misleading” facts on clinical trials of new drugs, which are contrary to the extant Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
The ministry has written to Prasoon Joshi, chairman of the censor board, asking him to postpone its release.
Its complaint is based on the trailer of the film.
“From the trailer of the film, it appears that a lot of distorted and misleading facts on clinical trials of new drugs are being presented in the said film and the issues dealt in the film are contrary to the existing Act. This ministry has serious objections to the release of this film,” the health ministry said in a letter dated 12 September.
Mint has reviewed the copy of the letter sent to Joshi.
Umeed, which is a directorial debut of Rajat S. Mukherjee, was earlier supposed to be released on 22 September, and is based on drug trials in India. The protagonist Mia (Pallavi Das), shows how pharma companies use celebrities to give “unethical clinical trials” a mask of vaccination programmes.
Earlier in August, the film was examined by the examination committee of CBFC, which failed to reach a consensus or a clear majority.
Due to the difference of opinion, the chairman referred it to the revising committee of CBFC, which examined the film and recommended A category with certain cuts. The movie makers have applied afresh to the CBFC with a revised version after making voluntary deletions. The decision on the release of the film is yet to be taken.
Last week, the movie was screened for the ministry officials at an unknown location.
Health ministry officials said the release of the film “is likely to bring bad name on clinical trials in particular and Indian pharmaceutical sector in general.”
The movie, however, failed to impress the ministry officials. “The film shows that India is market to unethical trials, which is not the case. If we project that we do not have a stringent regulatory environment, the drug makers will move their trials to other locations,” an official privy to the matter said.
The clinical trial research in India has seen a lot of hurdles in the past too and the officials do not want further complications due to the release of the film.
In 2013, the Supreme Court had stopped the Central Drug Standard Control Organization (CDSCO) from allowing trials for new medicines over allegations of irregularities in the approval process. The court banned clinical trials for new chemical entities unless they were personally vetted and cleared by the health secretary. However, it was only after 2013 that major changes took place in the regulatory framework and the trials nosedived.
According to the data from the CDSCO, while only 73 trials got permission in 2013, it increased to 198 in 2014 and 116 in 2015-2016.
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