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To provide an in-depth understanding of the regulatory pathways and drug-medical device approval process via its Sugam portal, the Department of Biotechnology (DBT) along with the Central Drugs Standard Control Organisation (CDSCO) has lined up a series of six national workshops facilitating the resolution of regulatory concerns faced by innovator companies in the country. BIRAC and CDSA too chipped in its expertise.
The workshops are being organised by the government to spur its Make in India programme in sectors of pharmaceuticals, biotechnology, medical devices, in-vitro diagnostics, phytopharmaceuticals and vaccines as the government is of the view that it is critical for innovator companies and start-ups to interact with regulatory authorities directly to clarify issues that hamper their growth and development.
At a day-long session at the national workshop held in the C-CAMP (Centre for Cellular and Molecular Platform) campus in Bengaluru, around 100 participants had intensive deliberations to accelerate innovations across companies and start-ups in the sector.
Going by India’s capability in innovation which is set to transform drug delivery, manufacture of biologicals and new medical device development, Amaresh Tumbagi, drugs controller (in-charge), government of Karnataka said that taking a research from discovery to development spanned 10 years of time and investments. Therefore, it is important for the regulatory authorities both at the state and centre to guide and discuss with innovator companies and start-ups to prevent a failure during a regulatory submission.
“Selection of a drug target to lead optimisation takes anywhere from 1 to 5 years and we do see and hear of companies facing insurmountable stumbling blocks. This is where consultations between companies and regulators could offset much of the crisis”, he added.
Karnataka drugs control department has put in place a rigorous drug approval system. It has also 22 services coming under the ‘Sakala’ which mandates timelines for services and penalises its officers for failing to stick to the stipulated deadline. This augurs well for the growing innovative companies in the state which is a hub for pharma, biotech and medical device manufacture, said Tumbagi.
“Even if any product that is developed did not come under the ambit of regulation, efforts would be made by our state drugs control department to understand the novel technology process and discuss with the central drugs & devices regulatory authority on its importance. We would also work together with the CDSCO to introduce a clause in the existing regulatory note to ensure that such an innovation comes under the regulatory pathway for approval,” said Tumbagi.
Providing a peek into the drug regulations in India along with an overview of the CDSCO structure, approval process, checklist for application submission via Sugam online portal and fee structure, Dr. B Kumar, deputy Drugs Controller General of India, CDSCO, Sub-Zonal office, Bengaluru said that the aim was to strengthen the regulations, remain updated and move towards a PIC/S regime for India.
Dr. Taslimarif Saiyed, CEO and director, C-CAMP said that since its campus houses several start-ups, it was a mediator airing concerns of the innovators to the regulatory authorities. A decision to have a portal with queries from the innovators to the regulator was on the cards.
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