How to Avoid a Bad Trip
When Prime Minister Narendra Modi had announced the ambitious ‘Make in India’ agenda on August 15, 2015, he was careful to include a second mission statement: ‘Zero Defect, Zero Effect’. “We should manufacture goods in such a way that they carry zero defect and that our exported goods are never returned to us. We should manufacture goods with zero effect that they should not have a negative impact on the environment,” he had clearly stated.
The truth of the matter, as reported in ET (goo.gl/1OYYjX), is that the US Food and Drug Administration (USFDA) rejected 13,334 Indian-made food and drug products over the last five years, just slightly less than the 15,087 rejected Chinese-made products, despite the fact that China is the US’ third-largest trading partner, while India is the 11th. In addition to the rejections, the USFDA has slapped import bans on approximately 44 pharmaceutical manufacturing plants located in India because of poor compliance with good manufacturing practices.
The story regarding Indian food and drug exports to Europe is no better. According to data available on the European Commission’s website, the countries constituting the European Union (EU) rejected consignments, issued alerts or sought more information in a total of 1,431 cases of import of food or agricultural products from India during 2011-16 due to contaminations or infestations or use of prohibited substances such as antibiotics.
In 2014, the European Commission’s Standing Committee on Public Health imposed an import ban on a range of farm products like Alphonso mangoes, eggplant, taro plant, bitter gourd and snake gourd, because of contaminations and infestations. In 2015, the EU cancelled 700 drug approvals because the supporting safety data generated at GVK Bio was suspected of being either manipulated or fabricated.
What is the government doing to rectify the situation? Ministers under pressure to show growth of industries are either in denial or choose to ignore the quality issue. For example, last year, Union food processing minister Harsimrat Kaur Badal complained that the Food Safety and Standards Authority of India was a new ‘inspector raj’ threatening the government’s ‘Make in India’ initiative, stalling overseas investment and killing innovation. Her colleague Nirmala Sitharaman, the minister of commerce, responded to the GVK Bio issue by first cancelling long-pending trade talks with the EU before reversing that decision and agreeing to speak to the EU.
The main vehicle for Modi’s ‘Zero Defect, Zero Effect’ campaign is the Quality Council of India (QCI), an autonomous institution set up by the department of industrial policy and promotion (Dipp) in 1996 with the stated mission of improving “quality standards in all important spheres of activities including education, healthcare, environment protection, governance, social sectors, infrastructure sector and such other areas of organised activities”. In the last few years, the QCI has maintained a blessed silence on the severe quality issues being faced by the pharmaceutical industry despite the fact that the industry’s reputation is taking a beating on the international scene because of a series of scandals.
More worryingly, since its inception, the QCI’s emphasis has been on creating voluntary accreditation schemes such as the National Accreditation Board for Hospitals and Healthcare Providers and the National Accreditation Board for Education and Training. Modi’s call for ‘zero defects’ led the QCI to merely create a new certification scheme, called ‘ZED Certification’ for the micro, small and medium enterprises (MSME) industry.
The ZED certification is described as “an integrated and holistic certification system that will account for quality, productivity, energy efficiency, pollution mitigation, financial status, human resource and technological depth including design and IPR [intellectual property rights] in both products and processes”. Given the difficulty the government faces in enforcing mandatory laws, it is doubtful whether voluntary accreditation schemes are the best way to increase quality standards.
More problematically, in the context of food and drugs, there is little discussion either at the QCI or within the government on how best to tackle the current nightmarish scenario posed to public health in India and what we export. As highlighted by the food minister’s and commerce minister’s words and actions, it is unrealistic to believe that ministries responsible for the growth of industry are going to initiate a conversation on quality control.
The country needs the conversation to begin from outside the government. The QCI is in a unique position to redefine its mission and lead the charge. It is high time it does so.
The writer is executive chairman, Medassure Global Compliance Corporation
Uh-oh, I just popped a pill made in India