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New Delhi: In a first, the Drug Controller General of India (DCGI) have given approval to a chain of dermatology and plastic surgery centres— The Esthetic Clinics, for conducting clinical trials and drug development for skin, hair and other plastic surgery medications, cosmetology and cosmetic surgery devices in India.
At present, clinical trials are not mandated for every cosmetic product that enters Indian market provided it is approved in other markets. There are a few clinical trials that are conducted by clinical research organisations in India, but they do not have the clinical acumen in cosmetic, plastic or aesthetic segment. Majority of clinical trial centers work in pharmaceutical drug development, but not for cosmetic and aesthetic solutions.
“Caring for skin and hair is a business where unmet needs still abound and people around the world are waiting for newer and better solutions. Considering India now has the clinical acumen and have the ratification of the DCGI & CDSCO to conduct clinical trials for top quality cosmetic needs, far more newer products and technology will be hitting the Indian market than before. MNCs, as well as homegrown companies, can easily enter the Indian market at much lower costs, keeping in mind local needs”, says Dr Debraj Shome, director, The Esthetic Clinics.
The DCGI under CDSCO is the supreme regulatory authority in India which gives recognition to clinical establishments, hospitals, and organisations based on a set of parameters/guidelines to perform clinical research. These guidelines are aimed to protect patient rights and ensure products fulfill quality standards.
Many products in cosmetology and aesthetics are launched in India based on clinical trials conducted overseas on caucasians or black population and not on the Indian population. "Indian skin is different and therefore it's response to medicines is different. Hence, it becomes important to do clinical trials in our particular population where the product is going to be launched, instead of performing the same in a completely diverse population”, says Dr Rinky Kapoor, director, The Esthetic Clinics.
The Esthetic Clinics has around nine centers across India with 6 centers in Mumbai and one each in Hyderabad, Kolkata, Surat and Delhi.