Indian Pharma’s Regulation & Compliance Skill Gap Needs Effective Training

Pharmaceutical and life science companies must comply with many rules and regulations enforced by government and its designated bodies and operate in a highly regulated but profitable industry. Worldwide, the regulatory bodies are established to frame and audit the quality enforcement requirements, legal protection of IP, and drug development-to-trial-to-approval process in a country. As medicines and vaccines have been critical for health, well-being and immunity-building or cures of living beings especially humans, there are regulations to ensure the quality, safety and efficacy of these drugs.  

The employees involved in Quality Assurance act as the crucial link between enabling the companies’ sales force to comply and meet the guidelines of the regulatory authorities enabling them to keep the compliance index of their respective companies high, while at the same time ensuring they find the right markets for their product. Due to stringent and evolving complexities in the quality and compliance world of global regulatory agencies, and specifically to Europe and USA, the export-focussed Indian pharmaceutical companies need to comply with stringent quality standards and process documentation. Impacted by warning letters and import recalls due to compliance and regulatory issues, Indian pharmaceutical companies are waking up to need reskilling and upskilling their QA/ QC and Shop-floor employees. They have realised that internal skilling can only perpetuate the skills learned in the past whereas the need of the hour is for employees to be skilled to a certain standard and quality recognised globally. The internal efforts at skilling have not yet shown the desired outcomes in terms of stopping the warning letters from USFDA, and the impact of this far outweighs costs of skilling the employees using a global standard. It is not financially viable for these companies to fly in expert trainers and consultants from USA, since their ability to keep costs under control is important to remain competitive in the domestic and international market.

The demand for compliance and regulatory skills continues to grow but graduates entering the workforce are ill prepared to ensure compliance with regulations set by agencies like The Food and Drug Administration of the United States (USFDA), The European Medicines Agency (EMA) or The Central Drugs Standard Control Organisation (CDSCO). The severity of the skill gap in India’s pharma sector can be judged from a Deloitte survey where 64 per cent of survey respondents attributed non-compliance to shortage of skilled staff in their Manufacturing and Quality Assurance teams.

The National Skill Development Corporation (NDSC), a skill development & entrepreneurship agency in its study as well has reported a major skill deficit in human resources for Indian pharmaceutical industry.

Big and small, all kinds of pharma companies are failing cGMP to assure safety and efficacy of drug products. This emphasises the importance of right hiring, right training and a right environment where compliance and safety are considered pious. The paucity of skilled trained graduates leads to sub-optimal hiring – both in terms of quality of manpower and quantity as per requirement. Drug companies have been taking the easy way out by scouting for the best ‘experienced’ talent from competition to fill the skill gap – but in the process this has created a spiral of increasing costs for the industry. The expansion in international and domestic market has kept companies looking for competent staff not just in India, but even as ‘expatriate’ talent from India to those locations globally where local hiring is not mandatory.

Manipal ProLearn is solving for the Pharma Industry by launching its School of Pharma, with UL as its content and certification partner. Manipal ProLearn not only filters talent through extensive assessment using the globally acclaimed online assessment tools from MeritTrac but follows through by training them appropriately while customising some of the modules as per client requirements. The Training has a high ‘experiential’ component of 70% achieved through specific practical training and on-the-job training.

Short-duration Training Programs: India has the highest number of GMP-approved pharmaceutical manufacturing plants outside the United States and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. By addressing this pressing industry need, Manipal ProLearn offers customised pharmaceutical quality management (PQM/ TQM) Training programs for junior and mid-level employees. The programs are conducted by UL trained and certified trainers from Manipal ProLearn. Functional programs are aimed at empowering participants in a specific domain or function. The programs provide the critical quality and compliance learning resources to achieve and maintain organisation goals of high product quality, safety and compliance with escalating regulatory demands.

 

For more on the Manipal ProLearn School of Pharma in collaboration with UL, please reach out to Sanjeev.goel@manipalglobal.com