In order to achieve quality, compliance and patient safety, the Central Drugs Standard Control Organisation (CDSCO) is rationalising the drug regulations in consultation with global regulatory experts. This, according to the Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi, will be done towards ease of doing business and developing a quality culture.
Speaking on the sidelines of a panel discussion on Quality, Compliance and Patient Safety at the 9th International Pharmaceutical Exhibition (iPHEX) in Hyderabad, the DCGI said this is very much required as the pharma industry is projected as a US$ 500 billion opportunity by 2047.
The event which was hosted by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry began on July 5 and concluded on July 7, 2023.
“Regulations need to be designed in such a manner that it serves the purpose of quality for both big pharma and MSMEs. It has been observed that the compliance to drug regulations have been optimal for big pharma and sub -optimal for MSMEs. Besides that, it has also been observed that there has been non-uniformity in terms of interpretation and implementation of the law. Therefore, MSMEs will be supported by the CDSCO towards upgradation of skills to achieve global industry standards,” the DCGI said.
“Creating a balance in terms of implementing the law is a challenge as the country’s compliance requirements are huge considering the size of the industry and the country. This is also very much required as India is witnessing and implementing global regulatory harmonisation with active participation of the US, Europe and Japanese pharmacopeias,” Raghuvanshi added.
He further said that India story will continue to shine if we allow MSMEs also to move up the value chain by bringing in quality manpower and setting quality management systems (QMS).
“In order to create an ecosystem of quality, the Indian Pharmacopoeia Commission (IPC) has developed Adverse Drug Reaction (ADR) reporting form as a part of the Pharmacovigilance Programme of India (PvPI) to effectively report adverse events due to the usage of a medicinal product. Over the past ten years of inception of PvPI, it has generated 13 signals which is big milestone to achieve and hundreds of drug alerts,” Raghuvanshi informed.
Lakshmi Prasanna, director, Regulatory Affairs, Pharmexcil conducted the proceedings of the event.
Monday, July 10, 2023