The report is in complete contrast to the government’s own report of 2016. Photo: iStocke
The report is in complete contrast to the government’s own report of 2016. Photo: iStocke

Health ministry prepares rebuttal to USTR's counterfeit medicines report

  • Dismissing the report, Arun Singhal, Additional Secretary in the health ministry told Mint that the government is in the process of drafting a rebuttal
  • In its latest Special 301 report released by the USTR, it claimed that India and China were the leading sources of counterfeit medicines

The health ministry is readying a rebuttal to the US trade representatives (USTR), following its report that termed that India as one of the leading sources of counterfeit medicines distributed globally, a top government official said.

Dismissing the report, Arun Singhal, Additional Secretary in the health ministry told Mint that the government is in the process of drafting a rebuttal as it seeks details on the “vague" report by USTR. “We will be writing to them seeking evidence on their report. We want to know the basis and want concrete data from them for coming to such conclusion," he said.

In its latest Special 301 report released by the USTR, it claimed that India and China were the leading sources of counterfeit medicines distributed globally. “While it may not be possible to determine an exact figure studies have suggested that upto 20 per cent of the drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety," it said.

The report is in complete contrast to the government’s own report of 2016 that found only 3 per cent drugs of not of standard quality and 0.0245 per cent spurious drugs. “The survey included drugs belonging to all therapeutic categories. As part of the survey more than 47000 drug samples were drawn from various districts, states and UTs. The claim made by USTR tarnishes the image of India which is one of the leading global producers of low cost generic medicines and hence it’s important to get documentary evidence from them that they used to support their claim," said S Eswara Reddy, Drug Controller General of India (DCGI).

The USTR in its latest report also retained India on the “priority watch list" for its alleged poor enforcement of intellectual property regulations.

Calling it an unfair pressure by the US government, Leena Menghaney, South Asia head of the Access campaign by Médecins Sans Frontières said that “MSF supports the health Ministry's position that the USTR 301 Report is an attack on affordable generic drugs".

Rubbishing the report, Rajiv Nath, forum Coordinator AiMeD said India needs to refute the report. “There are two issues of IP protection and Quality of generics. India needs to refute the US TR 301 report with sharing of data and its own report on the extensive and excellent study done in India on counterfeit medicines that indicated no such issues of wide spread counterfeiting of 20% as is being claimed repeatedly over the years and prove this as a bogey that needlessly creates disharmony between worlds two great democracies. India has strong IP protection and a rapidly improving patent review and granting system. The USTR forwards claims of the powerful US lobby to the Indian Government. Government of India needs to similarly work with Indian subject experts for putting forth the Indian industry perspective and trade related issues and address their apprehensions".

Quoting a 2019 publication produced by the Organisation for Economic Co-operation and Development (OECD) USTR said India was among the top five provenance economies for counterfeit goods. A 2017 report from the OECD and the European Union Intellectual Property Office, ‘Mapping the Real Routes of Trade in Fake Goods,’ revealed India to be a key producer and exporter of counterfeit foodstuffs, pharmaceuticals, perfumes and cosmetics, textiles, footwear, electronics and electrical equipment, toys, games, and sporting equipment. The 2017 report also found that 55% of global seizures of counterfeit pharmaceuticals, by total value, originated in India —making it by far the largest producer," it added.

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