International pharma majors have now increased their expectations from emerging markets like India to adhere to a highly regulated environment with little flexibility.

Regulators globally have now developed a harmonized Pharmaceutical Quality System (PQS) applicable across the life cycle of the product emphasizing an integrated approach to the Quality Risk Management.

US FDA, European and Japanese regulators are focusing on a science-based approach in pharmaceutical development, complying to ICH Q8, Q9, Q10, Q11 (draft) and latest US FDA guidelines on ‘Process validation - life cycle approach’.

This has led Indian pharma companies from Aurobindo Pharma to Cipla, Dr Reddy’s and Ranbaxy along with small and medium scale enterprises engaged in exports to become more cautious about remaining stringent when it comes to quality norms in research and production.

As global majors view India not just for import of active pharmaceutical ingredients (APIs) and formulations, but as a prime hub for research, formulation development, clinical trials and contract manufacture, drug companies are now working in highly competitive environment and the regulatory expectations are an additional stress in meeting timelines, stated A G Raghu Head – Quality and Regulatory Affairs, Apotex Pharmachem India Pvt. Ltd., Bengaluru.

Yet Indian pharma is gearing up to get its act right the first time. Access to trained experts on global regulatory frameworks has been the focus, he added.

“Risk management plays an important role as there is a failure to achieve consistent results when we transfer the process from development-scale to production-scale. So pharmaceutical companies engaged in drug development should use Quality by Design approach to conform to the latest regulatory expectations. This involves lot of additional activity and poses a challenge in meeting tight timelines,” said Raghu.

The key factors to ensure total adherence to a rigorous regulatory environment would be to create a robust change in management. To achieve this, companies will need to establish a common and transparent premarket evaluation, post-market surveillance, uniform quality system with similar audit criteria, and common clinical safety performance, said Kaushik Desai, vice president and chairman, Industrial Pharmacy Division, IPA.

According to Dr Smita Singhania, vice president and head Regulatory Affairs, MabPharma Pvt. Ltd., Goa, to develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product requires  an integrated approach to quality risk management.

In order to overcome the challenges in regulatory submissions, Indian pharma companies will need to devise in-house strategies like good risk management, quality systems, design and control  approaches to remain competitive, stated Raghu.

Recent trends for science-based explanations on the analytical validation,  residual solvent control in drug substances and control of impurities like metallic residues and genotoxic contents involve additional work to generate the required data generation. Further there is also need to establish the acceptance criteria physical attributes like particle size which also plays major role as it has a significant effect on drug product performance. The mushrooming of patents in polymorphism also poses challenge to the selection of specific polymorph for the development of the drug product. “The only way for Indian companies to  reduce regulatory burden would be to adopt prudent good management systems in every stage of product development. The move would drastically decrease submission on changes or variations and inspection of quality systems,” pointed out Raghu.