The Drugs Controller General of India (DCGI) plans to set up a dedicated cell for supporting and regulating innovation and startups in the pharma sector. The announcement was made by Dr. Eswara Reddy, Newly Appointed Head of the DCGI.
The upcoming cell, preliminary named as Innovation Support and Regulatory Cell, will have a dedicated and trained staff to address the problems of innovators and start-ups. The proposed cell will be set up at the office of the Central Drugs Standard Control Organsiation at New Delhi within next two to three weeks.
Emphasising on a need to bridge the gap between regulators and innovators such pharma-based startups & entrepreneurs working on new-age drugs, Dr. Reddy said, "Many start-ups are also coming up in pharma and allied segments and are clueless about regulation, which is affecting their performance. Unless innovators and regulators work in close coordination, industry cannot come up with innovative products, which are the need of the hour."
A dedicated startup cell is required is required because often, innovators who are mostly scientists and researchers do not have knowledge of regulations and, as a result, face a lot of problems, he added.
Through the upcoming cell, big pharma players or even startups working on innovative products or solutions can indirectly approach DCGI at any stage for any purpose.
The above news was first reported in The New Indian Express.
The newly appointed DCGI head Dr. Reddy also said that the major priority of DCGI is how it can do ease of doing business in its system and thereby how can it promote Make in India and drug discovery in India.
DCGI is under the gamut of Central Drugs Standard Control Organization, which is a regulatory body for India pharmaceuticals and medical devices. DCGI is primarily responsible for approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
Earlier in 2016, when DCGI was headed by Dr. G.N. Singh, a temporary ban was placed on selling medicines online by DGCI due to business affected to brick and mortar pharmacist by e-pharma companies such as Healthkart, Practo and NetMeds, among others.
This time however DCGI is more focussing towards innovation in pharmaceutical and drug making, and help startups specifically to cut off hindrances it get while making such efforts.
It is to be noted that in last couple of years significant number of startups have had showcased their innovation in pharmaceutical and new-age drug production. For an instance, Bengaluru based Pandorum, which recently raised ₹ 23 crore, is currently working on bioengineering human cornea that can potentially be implanted. Its 3D-printed human tissues can be used for drug development and medical research.
Another, drug based startup from Bengaluru Axio Biosolutions has patented and CE-approved product that has prevented countless deaths due to haemorrhage and grievous injuries. The startup has recently raised $7.4 million from Ratan Tata's RNT Capital.
The upcoming cell, preliminary named as Innovation Support and Regulatory Cell, will have a dedicated and trained staff to address the problems of innovators and start-ups. The proposed cell will be set up at the office of the Central Drugs Standard Control Organsiation at New Delhi within next two to three weeks.
Emphasising on a need to bridge the gap between regulators and innovators such pharma-based startups & entrepreneurs working on new-age drugs, Dr. Reddy said, "Many start-ups are also coming up in pharma and allied segments and are clueless about regulation, which is affecting their performance. Unless innovators and regulators work in close coordination, industry cannot come up with innovative products, which are the need of the hour."
A dedicated startup cell is required is required because often, innovators who are mostly scientists and researchers do not have knowledge of regulations and, as a result, face a lot of problems, he added.
Through the upcoming cell, big pharma players or even startups working on innovative products or solutions can indirectly approach DCGI at any stage for any purpose.
The above news was first reported in The New Indian Express.
The newly appointed DCGI head Dr. Reddy also said that the major priority of DCGI is how it can do ease of doing business in its system and thereby how can it promote Make in India and drug discovery in India.
DCGI is under the gamut of Central Drugs Standard Control Organization, which is a regulatory body for India pharmaceuticals and medical devices. DCGI is primarily responsible for approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
Earlier in 2016, when DCGI was headed by Dr. G.N. Singh, a temporary ban was placed on selling medicines online by DGCI due to business affected to brick and mortar pharmacist by e-pharma companies such as Healthkart, Practo and NetMeds, among others.
This time however DCGI is more focussing towards innovation in pharmaceutical and drug making, and help startups specifically to cut off hindrances it get while making such efforts.
It is to be noted that in last couple of years significant number of startups have had showcased their innovation in pharmaceutical and new-age drug production. For an instance, Bengaluru based Pandorum, which recently raised ₹ 23 crore, is currently working on bioengineering human cornea that can potentially be implanted. Its 3D-printed human tissues can be used for drug development and medical research.
Another, drug based startup from Bengaluru Axio Biosolutions has patented and CE-approved product that has prevented countless deaths due to haemorrhage and grievous injuries. The startup has recently raised $7.4 million from Ratan Tata's RNT Capital.
Advertisements