Bringing and developing Regulatory Affairs profession in Indian pharma industry is initiative of Indian government in the interest of public health,by controlling and checking the strength,efficacy,purity,safety of pharmaceuticals,veterinary products,cosmetics,so as to deliver a quality product in Indian market.Regulatory Affairs is the one of the most regulated department in pharmaceuticals,biotechnology,medical devices industries and above all in clinical research organization(CROs).
Indian Pharma majors are confronting a stiff competition among themselves and all the major companies are eyeing India as one of the best destination for research and development investments.Again Indian government and various health regulatory bodies playing a pivotal role and taking tremendous steps to showcase India as the best destination for conducting their clinical trials.Since the cost for conducting clinical trials is one-fifth relatively to other countries.
In India there are many hospitals engaged for conducting clinical trials with ICH-GCP trained investigators.Due to the latest advancement in the technology,many MNCs are keen to allow phase-1 clinical trials for the molecules discovered abroad.
MNCs who did not choosen India earlier due to lack of global regulatory guidelnes are now approaching India because India has released it’s guidelines on global clinical trials. India now is a TRIPS compliant and already it had entered into product patent system in 2005.
Necessary action will be taken against those pharma companies which do not comply with schedule M and against counterfeit drug manufacture so they have to face dire consequences like life imprisonment and heavy penalties.
Indian Pharma majors are confronting a stiff competition among themselves and all the major companies are eyeing India as one of the best destination for research and development investments.Again Indian government and various health regulatory bodies playing a pivotal role and taking tremendous steps to showcase India as the best destination for conducting their clinical trials.Since the cost for conducting clinical trials is one-fifth relatively to other countries.
In India there are many hospitals engaged for conducting clinical trials with ICH-GCP trained investigators.Due to the latest advancement in the technology,many MNCs are keen to allow phase-1 clinical trials for the molecules discovered abroad.
MNCs who did not choosen India earlier due to lack of global regulatory guidelnes are now approaching India because India has released it’s guidelines on global clinical trials. India now is a TRIPS compliant and already it had entered into product patent system in 2005.
Necessary action will be taken against those pharma companies which do not comply with schedule M and against counterfeit drug manufacture so they have to face dire consequences like life imprisonment and heavy penalties.
Due to advancement in Indian regulatory system,its rapidly gaining the attention of different countries,as india will be the future destination for global clinical trials.
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Problems with post-operative care also fall under the heading of surgical malpractice. Failure to provide proper post-operative care can cause pain and may require another surgery.
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