India will soon become the member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) which aims at promoting public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration.
The announcement to this effect was made by Drugs Controller General of India (DCGI) Dr. VG Somani at Indian Pharmaceutical Alliance’s 5th India Pharmaceutical Forum held in Mumbai on February 27-28, 2020.
India is moving towards becoming member of ICH and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Currently, it is among 22 observers in ICH and will soon become member of it. Harmonisation is being worked across the agencies to avoid duplicacy in product registration.
The objective of the ICH is to promote public health through international harmonisation of technical requirements that contributes to the timely introduction of new medicines and continued availability of the approved medicines to patients, to the prevention of unnecessary duplication of clinical trials in humans, to the development, registration and manufacturing of safe, effective, and high quality medicines in an efficient and cost-effective manner, and to the minimisation of the use of animal testing without compromising safety and effectiveness.
To become a member of ICH, the country needs to follow certain guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), good clinical practice (GCP), etc as well as good regulatory practice, said Somani.
On the other hand, in order to become member of PIC/S, India needs support from domestic drug industry. A part of industry has supported the country’s initiative to become member of PIC/S but a section of industry is not supportive of it as they do not find any merit in it, he said.
The PIC/S membership will reduce the burden on drug regulators in terms of decreasing the repeated inspections by various drug regulators on drug units.
He stated that India needs to have catch up with the world by building trust, confidence, quality culture and simplicity of regulations, utilising technology, evolving regulatory mechanism, adopting risk based approach in all the activities and consultative approach.
The Drugs and Cosmetics Rules are being simplified by the Central Drugs Standard Control Organisation (CDSCO) to increase drug industry’s compliance with it, he informed.
Over the years CDSCO has introduced changes to the Drugs and Cosmetics Rules ranging from online submission, fast track approval, accelerated approval, breakthrough approval.