Skilling the Pharma employees on Regulatory Compliances
For many years, India has been one of the top manufacturers and exporters of hydroxychloroquine to fight malaria. With the onset of the Coronavirus in India, when apparently this medicine was found to be effective in curing the patients, and India started to build up stock for its emergency use and even stopped exporting it. This shows the importance of the Indian Pharma Industry.
Currently, Indian Pharma Manufacturing volume is the world’s third-largest and very soon will cross the US $55 billion. Also, it supplies more than 50 per cent of the global demand for various vaccines. At present, this industry supplies over 80 per cent of antiretroviral medicines to combat AIDS.
The Indian Pharma Industry including medicines and medical devices is generating US$43 billion. The Pharma sector contributes around 1.72 per cent of India’s GDP.
National and International Regulations Policies
The Pharma Industry is following the National Pharmaceutical Pricing Policy – 2012 guidelines regulated by the National Pharmaceutical Pricing Authority (NPAA) in pricing the medicines. Central Drugs Standard Control Organisation (CDSCO) ensures medicines regulatory requirements in India.
The Indian Pharma Industry needs to follow the guidelines of international regulatory authorities. The World Health Organization deals in medicine policy, intellectual property rights (IPR), technical coordination, and quality of medicines, supply chain, finance and traditional drugs. The USA is one of the largest markets for Indian Pharma Industries and for that India has to regularly follow the US Food and Drug Administration (USFDA) regulations.
Vital Role of the Pharma Workforce in Regulatory Compliance
In the dynamic Pharma Industry, the companies need to change their practices in order to comply with the frequent changes in regulations. The regulatory bodies conduct timely inspections and also have the authority to issue warnings/notice to the companies in case of non-compliance.
India has around 10,500 Pharma manufacturing units and over 3000 Pharmaceutical firms and for addressing the growing demand this industry will need to recruit more than 2 million staff members for sales, QA/QC, etc. in the next 5 years. As per the National Skill Development Corporation (NSDC) report, there is a skill gap in human resources for the Indian Pharma sector until 2022.
The Indian Pharma firms are now more dedicated to Research and Development (R&D) for developing advanced medicines and there is a requirement for upgrading or reskilling the existing experienced workforce.
In the Indian Pharma Industry, regulatory compliance is one of the most important domains. Therefore, to become future-ready, the Indian Pharma workforce must have more clarity on best manufacturing practices, implementations and regulations to drive quarter-over-quarter growth.