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P A Francis
Wednesday, August 9, 2017, 08:00 Hrs  [IST]

The Union health ministry is reported to be considering to do away with the mandatory three phase clinical trials before launching new drugs if they have proved their safety and efficacy in developed countries. For this exemption, these new drugs should have been approved and marketed for at least two years in the markets of European Union, UK, US, Australia, Canada and Japan. The health ministry already sent the draft proposal in this regard to the ministry of law and justice for clearance. Permission to market new drugs are usually granted by the regulatory authorities in any country including in India only after carefully assessing the adverse drug reactions during the clinical trials. The health ministry thinks that the decision can avoid unnecessary repetition of trials and speed up the introduction of new drugs in the country. The health ministry thinks that change in trial rules should make it easier for the pharmaceutical companies to introduce drugs in India which are already in use in regulated markets. Currently, apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, a large number of contract research organizations and Indian companies are doing clinical trials in India for more than 20 years.

The health ministry is probably right in holding the view that introduction of new drugs get delayed to the extend of five to six years in India after they are launched in the developed markets just because of the stipulation of fresh clinical trials in India too for marketing approval. Such a decision of the health ministry now will be of great advantage to multinational companies as they do not have to conduct highly expensive clinical trials, recruit subjects at high costs and wait for the approval of the regulatory authorities. And whatever new drugs are coming out are from the research labs of MNCs in the developed countries. Granting marketing permission to new drugs without clinical trials in India only on the ground that they are in the markets of developed countries for two years is may not be a perfect move. It is no secret that these developed countries had withdrawn some of the high profile drugs like rimonabant, rosiglitazone, nimesulide, cisapride and phenylpropanolamine from the market some years of their launches on account of serious side effects. And Indian drug regulator followed it up by recalling from Indian market also. All these drugs were introduced in various markets after three phase trials. No chemical drug is totally safe and a marketing permission is given after weighing the extent of benefit over its adverse reactions. Safety is more important than efficacy of a new drug so as to avoid serious injuries to patients. Therefore, a stricter evaluation of safety and efficacy of any new drug should be upon the regulators of individual countries.


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Vivek Hattangadi Aug 12, 2017 4:41 PM
This may not be a welcome move for Indian patients.
Ethnicity is one factor that may account for the observed differences in both pharmacokinetics and pharmacodynamics of drugs, resulting in variability in response to drug therapy.
There are many examples of variants in drug-metabolizing enzymes that could contribute to variability in exposure and drug response.
Genetic variability in a drug can even result in toxicity!
Take for instance carbamazepine.
The incidence of carbamazepine-induced Stevens–Johnson syndrome and toxic epidermal necrolysis is higher in Han Chinese than in whites.
Such differences will not come to light in the absence of Indian clinical trials before a new drug is introduced.

Pradeep Awasthi Aug 11, 2017 12:49 PM
Its quite interesting to see that union ministry is showing higher concern about safety of new launch molecule.
In country like India,which is considered to be underdevloped country,still shows high level of dependency on western countries,when it comes on researching new therapeutics for treating majority of diseases,and that has been only the reason,that new molecules are launch by different multinationals in India.
But the biggest limitation stands to be with newer molecule, is their safety and efficacy in clinical trials,and in the recent past there are so many molecule such as rosiglitazone,cisapride which has been banned overnight because of higher adverse reactions and death rates.
So it is imperative that the new launch molecule need to be scrutinize under real life population before marketing.
But still bigger surprise stands with newer antidiabetic drug teneligliptin which is launch back in 2015,a drug which
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