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ALLOWING DRUGS WITHOUT TRIALS

P A Francis | Thursday, March 12, 2015, 08:00 Hrs [IST]

A news report in a major financial daily in Mumbai last week said that the government might allow marketing of new drugs in India without local clinical trials if the drug is already approved for marketing in the US and European markets for four years. The justification for such a reported move is that it would lead to a faster introduction of latest therapies to benefit patients in the country. Currently, if any drug has to be introduced in India, even if it has been in the markets overseas for years, local trials have to be completed and marketing approval has to be obtained from DCGI. The report further said that out of a total 140 new drugs introduced in the world market between 2006 and 2010, only 39 are available in the Indian market, according to an IMS Health global study of 2012. The reported move of the Health ministry is being welcomed by multinationals and large Indian drug companies for obvious reasons. On the one hand, they can skip the mandatory phase III trials leading to saving of several lakhs of rupees and on the other the companies can launch the drugs in a vast market like India without any loss of time.

The very objective of conducting local trials of new drugs in the domestic market is to reassess the safety and effectiveness of the drugs on the Indian population. The local trials are necessary to help to determine if there are any ethnic differences that can alter the metabolism, efficacy and safety of the drug when administered to patients of different ethnic origins living in India. To grant blanket permission for any new drug to market in India on the ground that they are allowed to be sold in the US and European markets is not a prudent idea. There are instances of quite a few drugs withdrawn from these markets after three to four years of their launch because of serious adverse reactions in patients. It is not very uncommon in the US and Europe to submit fabricated trial data by the pharma companies with regulatory authorities and getting marketing approvals. In the light of all these facts, the health ministry needs to seriously consider granting of marketing approvals for untested drugs in the Indian market. In very rare cases, DCGI is already granting marketing approvals without local trials. What Prof. Ranjit Roy Chaudhury suggested in his report was that waiver of clinical trials on Indian population can be considered for new drugs only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions or diseases for which there is no cure.

Comments

KRIS RAMABADRAN	Mar 17, 2015 12:45 AM
Did Dr. Ranjit Roy define or give examples for national emergency cases, extreme urgency cases, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions or diseases for which there is no cure. We need clear descriptions. No umbrella statements should be allowed.

RK Sood	Mar 16, 2015 8:55 AM
"It is not very uncommon in the US and Europe to submit fabricated trial data by the pharma companies with regulatory authorities and getting marketing approvals"- this seems incorrect. Rather unethical trials are more common in developed countries including India.

Vivek Hattangadi	Mar 15, 2015 9:45 AM
Having been so closely associated with pharma companies in conducting clinical trials for new products, I think this a right step. They are just an eye-wash and meaningless. Consider the Indore incidence of 2008. Mentally deranged persons from a mental hospital were subjected to trial on dapoxetine, a drug for premature ejaculation. Such clinical trials evoke suspicion.

Ajay

Mar 12, 2015 12:52 PM

Are you serious, have you even read the 68th DTAB minutes properly. On page 6 Para 2, It says that the Subject Expert Committee may grant a waiver if the safety, efficacy, effectiveness and need of the drug is found favourable then only a waiver is to be granted along with an undertaking and plan to conduct a Post Marketing surveillance in the market for atleast 4 years. Kindly believe that the government has made laws which safeguards indian population at large. Imagine your near or dear ones is on his last stage of a disease and there is a approved drug abroad which can give him a new lease of life, but cannot be given because of the delay of conducting clinical trials a fresh in india post approval and marketing launch of that drug in developed economies. It's not always about saving money. Patients have all the right to access new treatment whenever they are available, rather than wait for a law which pushes the introduction of the drug maybe by 3-4 years in our country. Even the I