India’s New Year Resolution – sweeping update of regulations
The Indian Centre for Drug Safety and Control announced on 31 December 2014
a Bill to be introduced this year to update the Drugs and Cosmetics Act.
Features of the new legislation include:
- Medical Devices formally written into the Act
- New Section on Clinical Trials Regulation mandating Ethics Committee Review and providing for application in regulation of GCP requirements and for trial audits.
- Appointment of Medical Device Technical Advisory Board with broad remit to advise on all matters Medtech. Similarly a new Drug Advisory Board.
- Establishment of Drug, Device and Cosmetic Consultative Committee composed of National and State government membership.
- Power to establish or designate Central Drug Laboratories
- New Chapter on regulation of import, sale and manufacturer of Notified medical devices. This chapter introduces the concepts of “adulterated”, “misbranded” (borrowed from the US FDA) and “spurious” (i.e. counterfeit) devices.
- Provides for regulations to establish classifications, essential requirements, designate standards, adverse event reporting, designation of conformity assessment bodies – borrowing hevily from the GHTF model of regulation.
- Provides for customs agencies to enforce certain parts of the act relating to import and inspection.
- Various emergency powers to waive regulations or to prevent import, manufacture or supply of specified products.
- Introduces a new schedule of biologicals to be regulated which includes conventional biologicals (e.g. vaccines and blood products) but also gene therapies, stem cells and xenografts
The proposed legislation still retains the concept of “Notified” device. It remains to be seen if or how the Indian regulators may expand upon the current specified list of devices regulated.
This is a wide ranging update to Indian regulation and at this stage is a consultation draft. However if enacted it will be the most comprehensive reform of drug and device regulation in India in decades. There will need to be a substantial body of regulations to support all the new requirements in the Act.
It will be interesting to see if India can manage to move more quickly once this Act is passed, to develop the full regulatory infrastructure. Progress to date has been painfully slow. Perhaps this is signalling a renewed appetite for updating regulations in India?