New Delhi: Lack of adherence to “proper guidelines” is responsible for counterfeiting of drugs, loss of revenue and market share for Indian pharmaceutical industry, according to a whitepaper released by a lobby of foreign drug makers, the Organisation of Pharmaceutical Producers of India (OPPI).
The whitepaper was the result of a joint research conducted by the OPPI and Nexdigm (SKP), a multidisciplinary group that helps global organisations meet the needs of a dynamic business environment.
The paper, titled ‘Good Distribution Practices for Pharmaceutical Products’, highlighted loopholes in the distribution chain of pharma products in India and also suggested remedial measures
As many as 26 top foreign drugmakers have given their suggestions for the Indian pharmaceutical industry and also highlighted its strengths and loopholes in the 30-page report, which was shared with ThePrint.
It includes suggestions from Astra-Zeneca, Eli-Lilly, GlaxoSmithKline (GSK), Merck, Novartis India, Novo Nordisk India, Pfizer Ltd, Roche and Sanofi.
The drugmakers have highlighted that there have been “numerous instances”, which have caused both “health and reputational damage” to Indian pharma industry. The reason were “flaws or lacunae” in the distribution system of medicines, they added.
They further said that the drugs banned for sale or withdrawn by the Drugs Controller General of India “should not be available in the market, but lapses are often noticed”.
“While no system is foolproof and risk-free, it is essential that robust processes and rules are in place and constantly improved whenever market failures occur,” the report said.
The paper also pointed out that in the last two decades, quality standards for manufacturing medicines across the globe have been evolving and becoming more stringent.
“It is crucial to bring the local Indian standards to a minimum base for all manufacturers so that we eliminate quality differences between India and global markets,” it suggested.
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Distribution in India ‘still fragmented, unorganised’
The report emphasised that “the finished products are critical for restoring patient health. However, deteriorated, spurious, or damaged products can go beyond being ineffectual — they can also do immense harm to a consumer”.
The distribution and storage of pharmaceutical products, it said, require scientific processes, infrastructure, and controls that are diligently executed and carefully monitored.
The report said that “there have been numerous instances where such problems have arisen due to flaws or lacunae in the distribution system, causing both health and reputational damage”.
“We see numerous examples where Indian pharmaceutical firms have had to recall batches of products in international markets across a variety of categories like diabetes, gastritis/excess stomach acid, analgesics, and psychiatric medications.”
It further added that “complying with the stringent US Drug Supply Chain Security Act (DSCSC) has been challenging for domestic players”.
The DSCSC is executed by the US drug regulator Food and Drug Administration. India exports 40 per cent of generic medicines to the US out of its total production, according to the report.
It further suggested that “it is necessary for the Indian government to implement and enforce strict GDP [good distribution practices] guidelines similar to international standards such as WHO, PIC/S (Pharmaceutical Inspection Convention Scheme), etc., to ensure that product recalls are well handled with minimal risk to patients.”
According to the report, the finished product distribution component of the supply chain “needs immediate focus” and “attention from all stakeholders”.
It found that “today, distribution in India is still fragmented, unorganised, and characterised by wide variation in infrastructure quality, processes and systems, and technical capability”.
“This could put product integrity, quality, and patient safety at risk,” the report said.
Strength & capabilities
The report, however, also highlighted the strengths of the Indian pharmaceutical industry.
“While Covid-19 has brought global and national healthcare under scrutiny, the world continues to depend on Indian pharmaceutical and vaccine manufacturers substantially for their supply of medications,” it said.
The report added the Indian pharmaceutical industry has an important role in “promoting local and global health goals”.
“Rightly hailed as the ‘Pharmacy to the World,’ Indian pharma is home to over 3,000 manufacturers and around 10,500 manufacturing units, with domestic annual revenue of $20 billion as of 2019.”
It said India’s role in manufacturing affordable medicines, particularly generic drugs, makes the industry critical in the global landscape, adding that India is the world’s third largest manufacturer by volume.
“As India moves to achieve the goal of ‘One Nation, One Drug,’ the quality gap between export and domestic markets needs to be eliminated,” said Dr Nimish Shah, vice-president, Sales and Marketing, North America region and Corporate Services, Nexdigm, in the report.
“While the initiative requires significant monetary and policy investment, the clear and tangible benefits to stakeholders in the medium to long run certainly justify it,” he added.
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