India’s apex quality facilitation and national accreditation body Quality Council of India (QCI) is planning to launch voluntary certification schemes for good manufacturing practices (GMP), good distribution practices (GDP) and good pharmacy practices (GPP) based on World Health Organisation (WHO) guidelines with the support of Union health ministry and WHO.

QCI will constitute a steering committee and a technical committee supported by specific working groups represented by relevant stakeholders to drive the process.

QCI on March 15, 2016 had launched the voluntary certification scheme named Indian Certification for Medical Devices Scheme (ICMED) - the first indigenously developed international class certification scheme for the medical devices in India to reduce time and cost-run for obtaining globally accepted quality certification for Indian companies thus eliminating the malpractices of sub-standard or fraudulent certification or quality audits.
 
An initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with QCI and the National Accreditation Board for Certification Bodies (NABCB), ICMED is aimed at enhancing patient safety and providing consumer protection and much needed product credentials to manufacturers for instilling confidence among buyers and users.

ICMED is aimed to fill a big regulatory void as there was no India-specific official quality assurance system till date, due to which Indian medical device manufacturer’s encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits.

The scheme is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market, thereby ensuring substantial savings, enhanced credibility and increased competitiveness for Indian manufacturers.

ICMED has two options for certification, one being ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ and other being ‘ICMED 13485 (An ISO 13485 Plus additional requirements).