India will soon start work on creating a blueprint strategy with a clear-cut timeline to curb growth of spurious and not-of-standard medicines. This will entail a robust detection and authentication mechanism based on modern technologies to identify genuine quality and safe medicines from spurious and unsafe medicines in the supply chain and take prompt action against manufacturers and dealers trading with fake and unsafe medicines and violating our existing mandatory standards and provisions of the law under the Drugs & Cosmetics Act, 1940 (amended upto 2008).
At an international workshop, it was announced that Government of India, World Health Organization and Partnership for Safe Medicine (PSM) India will collaborate to find an effective mechanism to ensure patients safety prevail over commercial interest and regain consumer confidence in the existing supply chain. The need for the use of user-friendly technologies to make detection of spurious medicines in the 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, Partnership for Safe Medicines (PSM) India.
For its part, the Government of India 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 equipment. It has also considered giving price advantage to companies if they make their technology public beyond the 74 medicines notified in the DPCO that are subject to bar coding and regulatory tracing and tracking system.
Misra added, “Monitoring of, and control over the pharmaceuticals ought to be more stringent since it concerns health and safety of the citizens and especially in those cases where even minor lapses can lead to losses of life. But, unfortunately we, in India do 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, doesnot readily agree to share such information in a transparent and accountable manner. ”
Participants in the workshop included key government officials, regulatory bodies and leading civil society groups working in India in the interest of the patients and consumers. Key dignitaries included PK Pradhan, IAS, Secretary to the Government of India, Ministry of Health & Family Welfare; Dr Jagdish Prasad, Director General of Health Services, Government of India, CP Singh, IAS, Chairman, National Pharmaceutical Pricing Authority (NPPA) India. Dr Arun Kumar Panda, Joint Secretary to the Government of India, Ministry of Health & Family Welfare; Dr Nata Menabde, WHO Representative to India; Dr Michael Deats (WHO HQ) and Dr Madhur Gupta, (WHO India Country Office); Dr GN Singh, Drug Controller General of India; Anil Rajput, Chairman, FICCI CASCADE. Sudip Bandyopadhyay, Minister of State for Health & Family Welfare, Government of India was the chief guest at the event, who inaugurated the Workshop.
Expressing grave concern on the conflicting data on sale of spurious medicines in developing countries such as India, the stakeholders 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. 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.
Jeffrey Gren, Director, Office of Health and Consumer, Goods, US Department of Commerce said, “No doubt technology can play a major role to track and trace the menace of spurious drugs but the need of the hour is to evolve a more holistic approach that ensures involvement of all stakeholders in the supply chain.”
Acknowledging that the laws in India were adequate to deal with counterfeiters, officials 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 barcoding to name a few.
PSM India also will be conducting a study in the coming months by engaging with all the stakeholders, especially Government of India on making a comprehensive report on the level of spurious medicines in supply chain in India. This will be based on an agreed methodology arrived at and outlined by Former President of India Dr AP J Abdul Kalam at an event on October 3, 2011 organised by PSM India.
“The technology is cheap and affordable and does not cost more than Rs 1.50 for a strip or packet. Now everyone has a cell phone and basic know how of technology products. Therefore accessing technology for checking spurious drugs will not be difficult for patients,” informed Misra.
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