Skilling the Pharma workforce on Regulatory Compliances

For years, India has been one of the top two global leaders in manufacturing and exporting of hydroxychloroquine to combat malaria. With the outbreak of the Novel Coronavirus disease (Covid 19), this drug was initially found to be successful in curing the victims, and India stopped the export of this key medicine to build up enough stocks for the cure of those  who would be affected in India. This prompted the President of the US, Donald Trump, to issue a special request to the Indian government to send emergency supplies for meeting the growing demand of the large numbers affected by the pandemic in his country. This episode demonstrated the critical role being played globally by the Indian Pharmaceutical Industry. 

Indian Pharmaceutical manufacturing volume is currently the world’s third-largest and by value will soon reach US$55 billion. India is the largest producer of generic drugs and the industry supplies over 50% of global demand for various vaccines. It caters to 40% of total drug demand in the US and 25% of all medicine in the UK.¹ Currently, Indian pharmaceutical firms supply more than 80% of antiretroviral drugs to fight HIV/AIDS. The Biotech industry is expected to reach US$100 billion by 2025.

The pharma industry in India including drugs and medical devices is generating US$43 billion at a growth rate of 7-8% in drugs and 15-16% in the medical devices. The total pharma export stands at US$20 billion. The pharmaceutical sector contributes around 1.72% of India’s GDP. For years, pharma is a key sector where India has been having a net trade-surplus (exports > imports) and accounts for a global share of 20% by volume from exports of generic drugs.

The 100% foreign direct investment (FDI) attracts global pharmaceutical companies to India, and this is further giving an impetus to the sector to grow to US$100 billion and medical devices to US$25 billion by 2025. 

National & international regulations

The industry is following the guidelines of the National Pharmaceutical Pricing Policy-2012 regulated by National Pharmaceutical Pricing Authority (NPPA) in pricing the medicines. Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare ensures drug regulatory requirements in India. Drugs and Cosmetics Act 1940 regulates the import, manufacture, distribution and sales.

Likewise, the industry needs to comply with the guidelines of international bodies and regulatory authorities of the foreign market. World Health Organization (WHO) deals with medicines policy, intellectual property rights, financing and supply management, quality and safety, selection and rational use of medicines, technical co-operation, and traditional medicines. Since the US is one of the largest markets for Indian pharmaceutical products, the regulations of the US Food and Drug Administration (USFDA) are the ones which have the most far-reaching and critical consequences.

Time-to-time, the USFDA guidelines for industries get updated. All the drug and medical device producing plants with the USFDA certification across the globe are required to comply with the framework developed by this body. In 2019, Indian pharma companies received 336 Abbreviated New Drug Application (ANDA), and 76 tentative approval from USFDA. Between 2010 and 2019, Indian pharma companies received 5768 ANDAs and 1351 tentative approvals -  it is 35% of total approvals given by the USFDA globally.

Role of the workforce in regulatory compliance

Despite all the regulations, Indian pharma firms sometimes get warnings for not conforming their practices with guidelines and lead to a huge loss to the companies. As the industry operates in a dynamic environment, the companies need to alter their practices to comply with changes in regulations. The regulators conduct periodic inspections and issue warning/notice to the firms for non-compliance. Indian pharma firms, however, improved their quality and such warnings have drastically come down in recent years. 

For example, while in 2014, 21.2% of all firms inspected in India received Official Action Indicated (OAI) letters from the USFDA, this has reduced to 3.6% in 2018. On the non-action to the OAI notice receives warning which in turn affect the credit profiles of the pharma players. This highlights the importance of regulatory compliance.

The onus to comply with the USFDA framework is on the entire pharma workforce. As India is home to about 10,500 drug manufacturing units and more than 3,000 pharma companies, the sector will need to hire over 2 million employees over the next 5 years across the sales, quality assurance, quality control, packaging, documentation etc. However, the studies show a clear skill gap in the pharma industry in India. A report from National Skill Development Corporation (NSDC), has pointed out the skill deficit in human resources for the Indian pharmaceutical industry until 2022. 

As the pharma companies start focusing more on research and development, the talent development  efforts for upskilling of experienced employees needs to address the skill gaps in this function which keeps evolving. Along with domain knowledge, technology impact, soft skills, one of the most critical remains the regulatory compliance as the key skill needed in the pharma and allied life-sciences industry. Therefore, building the workforce with a complete understanding of good manufacturing practices (GMP) and regulations is necessary for every pharma organization to comply with the regulatory guidelines.

Need for a training institution

Institutions dedicated to the pharma sector, like the Manipal ProLearn School of Pharma in collaboration with UL, is a pan India institution to bridge the skill gap in students and entry-level professionals to cater to pharma corporates/ entrepreneurs in pharma and the life-sciences industry. UL is a global independent body for training and certification on health and safety with a special focus on the life-sciences industry. Together Manipal ProLearn and UL will be focused on training and certifying talent on Quality Assurance, Quality Control, Machine Operations and also a separate vertical for Sales roles in pharma.

The unified and standardized programs are delivered by high rated faculties with about 70% practical lab training to the learners across India. Other features of the School of Pharma include:

Ø  Blended Learning Program

Ø  A learning platform that engages and monitors learner’s progress

Ø  Case Study/ real-life experience-based training approach

Ø Analytics to provide better visibility on the learning progress of learners for corporates

Ø  Face-to-Face classroom training

Ø  Interactive discussions & role plays

Ø  Group discussion/quizzes

Ø  On-Job-Training to all participants

The Indian pharmaceutical and bioscience/life science industries are registering a steady growth and stand as a dominant player in the world. The demand for skilled and trained human resources is huge but the industry still faces a huge deficit in acquiring the skilled workforce. The only solution is to train the aspirants and entry-level employees with hands-on modules as soon as they are provisionally selected basis their aptitude and attitude, with basic levels of domain knowledge. Manipal ProLearn School of Pharma in collaboration with UL offers such training for the Indian pharma industry to prepare their future workforce in complying with the national and international regulatory frameworks, and hence, ensure seamless and productive output.

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¹ https://www.ibef.org/industry/pharmaceutical-india.aspx