Stakeholders urge the government to speed up an effective ‘track and trace’ system to maintain uniform standards for drugs
For the first time in India, as a pilot project, patients can get their medicines tested in accredited government-approved laboratories at extremely low costs with support from the Partnership for Safe Medicines (PSM) India Initiative.
The PSM India Initiative has also suggested that the Department of Consumer Affairs 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 organising public awareness workshops at the State and national levels with all the stakeholders to seek ownership into the process.
The pilot project will include uniform standards for drugs with tracking and tracing system across the supply chain with technology to be vendor neutral, based on best global standards, simple in implementation and affordable, especially for the small scale manufacturers.
There could be a “Centralised 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 could be integrated with the portals/data banks set up by other countries to exchange information on approved/banned/ recalled drugs.
“The government should also expedite the process of implementation of effective ‘track & trace’ systems already made mandatory for all products meant for export and domestic products which are under price control,” according to a draft for the proposed technology released by PSM India. The draft has been circulated among all stakeholders before the proposed pilot project is launched.
India must adopt a sound track and trace system across the supply chain. This will not only provide safety and quality medicines to the patients but also improve tax collection from pharmaceutical products and reduce drastically not-of-standards or spurious medicines from the supply chain, the draft proposal says. “This will establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said P.D. Sheth, vice president of the International Pharmaceutical Federation.
The PSM India Initiative has 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.
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 mindset 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 of PSM India.
According to the draft proposals, the 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 should be adhered to.
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, USFDA and other country regulatory agencies. Efforts shall be made to harmonise prevalent State and Central 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, the proposals said