Spurious medicines may soon become a thing of the past, if the strategy being chalked out for a strong ‘track and trace’ system for fakes takes root

Spurious and not-of-standard medicines could soon become a thing of the past as the government would soon start working on creating a blueprint strategy with a clear-cut timeline to curb their growth in the Indian market. The process will entail a robust detection and authentication mechanism based on modern technologies to identify genuine quality and safe medicines from counterfeit ones in the supply chain and take prompt action against manufacturers and dealers trading with fake and unsafe medicines and violating existing mandatory standards and provisions of the law under the Drugs & Cosmetics Act, 1940 (amended up to 2008).

The government, World Health Organisation and Partnership for Safe Medicine (PSM) India will collaborate to find an effective mechanism to ensure that patients’ safety prevail over commercial interest and regain consumer confidence in the existing supply chain.

“The partners will work closely to develop a blueprint with a specific timeline to design a strategy to implement the use of detection and authentication technologies to make spurious and unsafe medicines easily detectable and take prompt action against all such manufacturers who violate the laws and standards of our country by working closely with the State regulators and law enforcers,” said Bejon Misra, founder director of PSM India.

For its part, the government has demonstrated its commitment within the framework of World Health Organisation and has started upgrading the capacity of the State governments by equipping the State Drug Testing Laboratories with modern technology and latest rapid testing equipments. It has also considered giving price advantage to companies if they make their technology public beyond the 74 medicines notified in the Drugs Price Control Order that are subject to bar coding and regulatory tracing and tracking system.

Mr. Misra added, “Monitoring of and control over the pharmaceuticals ought to be more stringent since it concerns the health and safety of the citizens and especially in those cases where even minor lapses can lead to loss of life. In India, we have adequate regulations to check such malpractices but the enforcement mechanisms need to be further strengthened to ensure effective and efficient implementation. The industry uses technology only to check brand protection and market share but due to lack of uniform mandatory regulation, does not readily agree to share such information in a transparent and accountable manner. That has to change in the interest of the patient’s safety and accessibility to quality medicines. A strong “track and trace” system — which does not exist — could help identify fake drugs before they reach patients. It would also make recalls more efficient.”

Expressing grave concern about the conflicting data on sale of spurious medicines in developing countries such as India, the stakeholders at an international workshop held in New Delhi recently agreed on the need to develop a common framework under which such drugs can be studied in detail and also bringing clarity on the definition of spurious, which will be acceptable globally. The meet took cognisance of the fact that increased used of the Internet worldwide was indeed providing an anonymous marketplace for criminal counterfeiters trading and advertising spurious medicine. It was also alleged that a few countries were illegally using brand India to market such drugs overseas in their own interest. Experts cautioned, unless checked, this could undermine the image and credibility of the pharmaceutical manufacturing companies, especially the small and medium scale companies, who are the biggest contributor to low-cost medicines, not only in India but across the world.

Acknowledging that the laws in India were adequate to deal with counterfeiters, the participants were of the view that the regulators and industry needed to work in tandem to safeguard public health by availing latest technologies that facilitate consumers to make informed choice and access to quality medicine. Current technologies available to detect spurious medicines include serialisation, non-clonable packaging and 2D bar-coding to name a few.