Pharmaceutical News

Drug discovery regulatory framework costing the delivery of drug and pharmaceutical industry

The way drug regulatory framework is in place in country is the cause for frustration among Bio tech industry, especially among bio-pharma sectors says Dr Rashmi H.Barbhaiya CEO and Managing Director of Advinus Therapeutics Ltd, Mumbai

L.Raghunanda

4^th Estate

Bangalore

While it is expressed under different platform, even in committee level under ministry of health, govt of India from stage of protocol submission, pre -clinical drug trial test, it takes nearly 6 months in India for the drug to get approval for drug, which is not the case in US, European countries, this is costing the Indian Pharmaceutical industry.

Barbhaiya said “Advinus which had successfully come out under best clinical trial for discovery of molecule which could be therapeutic drug for cancer treatment when used among other bio- similar lost $ 4 billion just because of 18 months delay.

“Who is to account for the loss, who is the sufferer, at the end it is patient, when you want best affordable life saving drugs to be brought after various clinical trials and test, and proven under the efficacy, it need to be brought out being manufactured as drug , it is to too much frustrating type of regulatory framework

“ I just don’t know who came with that kind of story, under highest ethical practice followed within bio-pharma or for that matter any bio technology and allied industry clinical trials are normal procedure, that is what pharma co-vigilance is all about, need for scrutiny of drugs being recommended to humans.

No one is made guinea pigs, even if trials were made using rodents or other animals, it is receptive factor for such molecule and for drug and how one responds it is the factor, so with that much clinical trials.

“ Even under the most adverse condition under particular dosage it will tried on humans, somebody may ask question why it need to be tried on humans ? Because whatever drugs today discovered if it was discovered to treat human beings, it need to be tried on humans in later stage

“Clinical trials under different phases are well accepted, we are asking why so much delay once protocol submission made known under Investigation for New Drug (IND) and being approved by Drug Controller General of India (DCGI) why such kind of delay.

As of now each protocol under drug discovery procedure need to get approval from various ministry is it necessary? while going through clinical trial just see the protocol has to get clearance of ministry of environment and forestry, commerce and industry, Indian Animal Ethics Committee (IAEC) is something undoing .

When everybody from industry and academia, to research taken keen interest in drug discovery for new drugs, the first of disappointment comes with regulatory framework, this regulatory framework as to clinical trials, drug discovery need to be reviewed, there is need to speed up.