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OPPI’s summit discusses on importance of quality standards for pharma industry


Pharma companies, government bodies, patient activists and healthcare practitioners gather to discuss how quality can become a key differentiator for India’s pharma and healthcare sector

“Quality should be embedded in every stage of medicine-manufacturing, delivery chain-right from R&D laboratory to the pharmacy from where patients buy drugs. Quality is and should be the foremost differentiator of the pharma and healthcare system in India”, echoed the industry, patient groups, service providers and government bodies present at the Quality Summit, held recently in Mumbai.

The gathering was organised in collaboration with Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilisers, all major industry associations, viz, the Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers’ Association (IDMA) and Organisation of Pharmaceutical Producers of India (OPPI).

The agenda for the gathering was to deliberate on the following:

  • Align on the importance of setting and adopting best-in-class global quality standards for the pharma industry;
  • Bring all stakeholders together – regulators, industry and governments, both state and central – to create the enabling conditions for achieving this goal
  • Define the quality road map for India.

The event started off with Annaswamy Vaidheesh, President, OPPI & Vice President, South Asia & Managing Director, India, GlaxoSmithKline Pharmaceuticals, giving the welcome address and highlighting the need for quality being the differentiator and a key factor that gives companies a competitive advantage they desire.

While speaking to Express Pharma, Vaidheesh informed that the government and industry bodies had healthy discussions on improving the quality standards. Also, he highlighted that the government has conveyed to the industry that only quality drugs will be included in the NHPS programme.

“Indian pharma companies need to have some meaningful quality standards and believe that both the industry and government are working towards it. WHO-GMP is what we are promoting to bring in uniformity and minimum criteria in order to raise the current quality standards. Further on, today, we have urged the government to take a strong stance on quality procurement and supply chain process,” he said.

“Not many are aware that there are four acceptable quality standards for manufacturing drugs worldwide: Schedule M, WHO-GMP standards, US FDA and EU standards. While there have been intentions to move all schedule M manufacturers to becoming WHO GMP compliant, according to various reports, out of 10000 generic manufacturers in India only 1400 are WHO-GMP compliant. Moreover, there are only 523 US FDA approved facilities in India as of 2016,” informed industry sources.

Dr Sanjit Singh Lamba, Chair, OPPI Technical & Supply Chain Management Committee and Managing Director, Eisai Pharmaceuticals India, shared an interesting perspective on how sub-standard medicines impact patient safety and efficacy. He stressed upon the need to bring in quality standards in the entire procurement and supply chain process right from manufacturing of medicines to delivering to pharmacies and beyond to ensure that patients get the right quality of medicines. “There is an urgent need to include quality in the complete value chain,” he maintained.

Deepnath Roy Chowdhury, National President, IDMA, in his talk said, “Our industry has taken the lead in pledging support towards making global quality medicines,” he said. “We will do our utmost in maintaining our country’s leadership in providing quality affordable medicines and ensure that Indian pharmaceuticals continues to be the nation’s pride”.

Rajesh Maheshwari, Director, Project Planning and Implementation, Quality Council of India (QCI), spoke about QCI’s role and its various agencies that help companies and healthcare providers to improve and maintain quality within their organisations and products. This session was followed by two panel discussions that included veterans from the healthcare and pharma industry. The sessions were moderated by McKinsey, who was the knowledge partner for this conference.

The panelists for the first discussion were: Dr Ratna Devi, Founder, Indian Alliance of Patient Groups, Bejon Misra, Founder, Patient Safety & Access Initiative of India Foundation, Dr Shrikant Shimpi, Healthcare Practitioner, Rajesh Maheswari, Director, NABCB c/o Quality Council of India and Dr Muffazal Lakdawala, Laparoscopic & Obesity Surgeon.

The panelists in this discussion clearly pointed out that all quality parameters must include patient safety and satisfaction in the long run. The next panel discussion had Annaswamy Vaidheesh, President, OPPI, Deepnath Roy Chowdhury, President, IDMA, Dr Ajit Dangi, President & CEO, Danssen Consulting, Dr Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals, Ashwani Sood, Sr Director – Industrial Affairs, Sanofi India and Deepshika Jakate, Regional Quality Head – South Asia, GlaxoSmithKline Pharmaceuticals, as the panelist. They gave three significant lessons to the audience on need by the pharma industry to stop being mediocre while manufacturing medicines, pharma companies should not try to beat law but follow the law and be more significant to the Indian market and be price competitive.

Another important highlight of this discussion was on the need to move from a chemistry-centric approach for drug development to biologist and more advance genomics.

The day ended with PBN Prasad, Deputy Drugs Controller, CDSCO, West Zone, Mumbai raising concerns on the quality system followed within pharma laboratories and how this will impact the overall quality of medicines manufactured.

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