India chapter of PSM advocates uniform standards for drugs with tracing and tracking system

Patients in India can get their medicines tested in accredited Government-approved laboratories at extremely low cost with support from Partnership for Safe Medicines (PSM) India Initiative. “This will establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said PD Sheth, Vice President, International Pharmaceutical Federation.

A draft proposed methodology was released at the India Habitat Centre, New Delhi, for public comments and wide circulation amongst all the stakeholders, prior to its official launch. This proposed innovative initiative will be launched as a pilot to study the extent of spurious and not-of-standards medicines in India and adopt policies to ensure safety and quality in the supply chain.

PSM India Initiative strongly demanded formulation of global best standards for exported and domestic drugs made available in the supply chain through a robust detection technology to promote universal product identification system under the Indian Drugs and Cosmetics Act. It enable consumers to distinguish between spurious and genuine medicines.

According to a PSM India Report on ‘Patient Safety and Drug Detection Technology’ released recently by Keshav Desiraju, Secretary, Ministry of Health and Family Welfare, it was further revealed that India has more than 10,000 manufacturers of pharmaceutical products but very few qualify the standards of Good Manufacturing Practices (GMP).

“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,” said Bejon Misra, Founder, PSM India.

The Report of the International Workshop held in India in September 2012 further emphasised that 2D bar coding and a unique universal product identification system should become mandatory under the provisions of the existing Indian Drugs and Cosmetics Act. There are also no provisions relating to the same for imported drugs, which should also get included into the existing law. To facilitate efficient drug recalls, global standards and best regulatory practices, India must adopt a sound track & trace system across the supply chain. This will not only provide safety and quality medicines to the patients but also improve tax collection from pharma products and reduce drastically not-of-standards or spurious medicines from the supply chain.

Government of India should also expedite the process of implementation of effective ‘track & trace’ systems already made mandatory for all products meant for exports and domestic products which are under price control. The technology to be selected should be vendor neutral, based on best global standards, simple in implementation and affordable, especially for the small scale manufacturers.

Adequate reference standards need to be made available to laboratories to keep up with new types of formulations and Indian regulatory officials should be invited as observers in the inspections of manufacturing sites by European Union, US FDA and other country regulatory agencies.

Efforts shall be made to harmonise prevalent State and Central Government regulations to facilitate compliance on varied traceability and recall requirements in a uniform manner following open, global and interoperable standards. Service providers and the patient groups shall play a major role in educating consumers about spurious and not-of-standard quality drugs with active support from Government of India.

There should be a ‘Centralized Data Bank’ posted on a website on a regular basis for all information relating to approved/banned/recalled drugs and it should be capable of being accessed by all state drug control authorities. Such portal should have features that it could be integrated with the portals/data banks set up by other countries to exchange information on approved/banned/ recalled drugs.

Indian industry associations, both big and small, should commit themselves to quality with appropriate self regulations, ensuring an effective cross checking process, including best practices in manufacturing, distribution and storage of medicines.

Department of Consumer Affairs of Government of India should allocate substantial resources for creating patient safety public awareness multi-media publicity campaign under the on-going ‘Jago Grahak Jago’ initiative. This can also be undertaken by organining public awareness workshops at state and regional level with all the stakeholders to seek ownership into the process.

EP News Bureau – Mumbai