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 There is a need for ushering in industry and regulator collaboration towards building trust to attain the common goal of quality and compliance. It has been urged to consider regulators as facilitators and the revised Schedule M as a tool to achieve compliance and drug quality. Harnessing the power of artificial intelligence (AI) to bring in predictive analysis in the systems and operations in the pharma industry was also discussed.
The deliberations took place at the two-day 24th Pharmaceutical Analysts Convention (PAC) held in Mumbai between December 16 and 17, 2025 under the theme “Sustainable Quality Excellence Through Regulatory Compliance and Technological Innovation”. The Convention was organised by the Indian Drug Manufacturers’ Association (IDMA).
While moderating the panel discussion on Sustainability in GMP: Regulatory Expectations & Industry Efforts, S M Mudda, chairman, Regulatory Affairs Committee - IDMA & managing director, Misom Labs – Malta said that Indian pharma industry voluntary movement toward system-driven quality is, in many ways, the most encouraging development in India’s pharma quality journey. India today supplies medicines to more than 220 countries, including Europe and the United States. This global position has not come by chance. It has come through learning, correction, and steady system building.
The revised Schedule M has arrived at a very important inflection point in our quality journey. At this stage, global regulatory expectations are rising, Indian regulation has become structurally stronger, and industry capability exists at different levels from large organisations to MSMEs. Recent developments have also served as a reminder that gaps in systems, wherever they exist, eventually surface, reinforcing why this transition is so important.
“Against this background, it is necessary for both government and industry to embrace the revised Schedule M, not as a checklist exercise, but as a means to move from fragmented compliance toward uniform, scalable, and consistent quality systems across the country, with clear leadership ownership,” Mudda explained.
While sharing his experience about having a balanced approach in regulatory oversight for the pharma industry, Dr. Hemant G. Koshia, former commissioner, Food and Drugs Control Administration (FDA), Gujarat said that by creating an enabling environment for manufacturers, a lot of quality issues were resolved. There has been a decline in not-of -standard (NSQ) drugs from 29% in 1970s to around 3% to 4% in 2025.
S W Deshpande, former joint commissioner, FDA, Maharashtra & proprietor – Pharmalex said there is a need for a shift from penal measure towards compliance-oriented implementation. Industry need to collaborate with the regulator for the single objective of consumer and patient safety.
Jyoti Sardesai, former director, FDA, Goa said that due to an enabling environment towards understanding compliance for manufacturers since 1975 onwards, there has been an increasing trend for ease of doing business (EoDB) in the pharma sector in Goa. Besides this, the Goa Directorate of Food and Drugs Administration (Goa DFDA) has also been granted Observer status for inspections with the US FDA, a significant step towards aligning the state's pharmaceutical sector with international quality and compliance standards
Dr S V Veeramani, chairman & managing director, Fourrts (India) Laboratories Pvt Ltd said that there is a need training for micro, small and medium enterprises (MSMEs) to implement revised Schedule M compliance effectively towards patient centricity and patient safety. The desired objectives can be achieved through a positive mindset towards compliance and maximum adoption of schemes like Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS).
Dr Viranchi Shah, national spokesperson, Indian Drug Manufacturers’ Association (IDMA) & director, Saga Lifesciences spoke about the judicious use of resources in the drug manufacturing facility to attain drug quality. “The manufacturer should focus on producing specific molecules based on the resources available as pharma MSMEs generally have limited resources and financial constraints. Revised Schedule M compliance should be looked as a tool to achieve quality.”
During the event, Vector Consulting Group gave a presentation and released a White Paper on Mind the G.A.P. Rethinking digital investments in the pharmaceutical industry authored by Chandrachur Datta, Dr. Shelja Jose Kuruvila, Abhinav Srivastava and Mayuresh Satpute.
This white paper combines quantitative evidence, case studies and illustrative examples to help pharma leaders move from digital ambition to measurable business results.
Moderated by Mehul Shah, vice president (Western Region), IDMA and promoter & managing director, Encube Ethicals, a panel discussion on Embedding Quality with AI: Redefining Standards of Excellence discussed the potential of AI in bringing efficiencies in the pharma industry.
While sharing his experience, Umang Vohra, MD & CEO, Cipla Limited said that AI and machine learning (ML) can effectively bring transparency and efficiency in pharma operations if used properly for effective prediction of drug quality and pharmaceutical systems.
Bhushan Akshikar, managing director, GlaxoSmithKline Pharmaceuticals Limited said that AI has the power to fuel intelligent automation. Therefore, there is a need to embed AI across the pharma value chain. AI and ML can help significantly contribute to R&D. Predictive analysis can also significantly contribute in drug discovery, clinical trials and patient follow up.
Nagarajan Thyagarajapuram, AVP - manufacturing&quality technical hub, Eli Lilly India spoke on AI ability to structure data and the power of predictive analysis in the pharma sector.
Vishwa Savla, managing director, Pinnacle Lifesciences said that AI can handle quality functions in the pharma as there are heavy chances of human errors or dependency.
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