On February 15, 2013 at the India Habitat Centre in New Delhi, the Partnership for Safe Medicines India proposed an initiative “to study the extent of spurious and not-of-standard medicines in India and adopt policies to ensure safety and quality in the supply chain.”

An unprecedented pilot program supported by the PSM India will provide low-cost medicine evaluation for patients at accredited government approved laboratories. The goal of the pilot program is to “establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said P. D. Sheth, VP, International Pharmaceutical Federation.

Shri Keshav Desiraju

Shri Keshav Desiraju, Secretary, Health and Family Welfare, Govt. of India
delivering Inaugural Address at the Open House Consultation on Accessibility to
Safe and Quality Medicines in the Supply Chain in India in New Delhi February 15, 2013.

On February 15, 2013 at the India Habitat Centre in New Delhi, the Partnership for Safe Medicines India proposed an initiative “to study the extent of spurious and not-of-standard medicines in India and adopt policies to ensure safety and quality in the supply chain.”

An unprecedented pilot program supported by the PSM India will provide low-cost medicine evaluation for patients at accredited government approved laboratories. The goal of the pilot program is to “establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said P. D. Sheth, VP, International Pharmaceutical Federation.

According to the February 15th report, “Patient Safety and Drug Detection Technology” released by Keshav Desiraju, Secretary of the Ministry of Health and Family Welfare, there are more than 10,000 pharmaceutical manufacturers in India, but “very few” meet the standards of Good Manufacturing Practices (GMP).

Said PSM India Founder Bejon Misra, “The real challenge is to change the mind-set of the small scale manufacturing units and make them understand that manufacturing good quality medicines will fetch profit and bring good return on investments rather than perpetually living under the threat of the law enforcers or in the mercy of the unscrupulous traders/retailers.”

At a previous workshop on September 10th, 2012, organized by PSM India in collaboration with the Ministry of Health and Family Welfare, Government of India and World Health Organization (WHO) India Country Office more than 50 eminent experts participated representing countries from Europe, North America, Asia, South America and Africa endorsed 2D barcoding and a standard product identification system as mandatory provisions of the Indian Drugs and Cosmetics Act. In order to better meet global standards, as well as facilitate efficient product recalls, the workshop participants recommended that government officials expedite a track and trace system that would extend across the supply chain in India in a report entitled “Report of the International Workshop on Patient Safety and Strengthening Drug Detection Technology.” Additionally, the participants recommended the renewal of pharmacopeia reference standards available for laboratories. Lastly, the participants called upon patient groups and service providers to develop robust consumer education campaigns on the risks of spurious and not-of-standard quality medications with the support of the Indian government.

Read the proposal for the pilot testing program here.

Read the full Patient Safety and Strengthening Drug Detection Technology report here.

By S. Imber