Train to Gain
A series of warning letters by the US FDA to Indian pharmaceutical companies have sent ripples of disquiet across the pharma sector. This development has come as no less than a humiliation for the industry that boasts of being the third largest in the world. Indian drug companies will have to work even harder to regain ground.
Part of the reason for these issues is the ever changing regulations across various geographies. Hence companies will have to ensure their employees are in sync with developments across the globe. Training is an important part of keeping up-to-date but it is vital that managements choose the right institute and trainers to meet Good Manufacturing Practice (GMP) compliance-related expectations of regulators ranging from the US FDA, MHRA, and the like. This business need has made pharma GMP training institutes a valuable partner for export-oriented pharma companies.
Growth drivers
As expected, there has been a steady rise in the number of pharma training institutes in India over the last decade as more pharma professionals queue up.
 “If training is expensive, try ignorance.” Atul Shirgaonkar CEO, Insight Systems |
Atul Shirgaonkar, Chief Executive Officer, Insight Systems, says, “The changing scenario in global GMPs has made training institutes a necessity. Many new requirements are being issued by regulatory agencies, particularly the US FDA, EU and WHO GMP. The challenge for successful organisations is to stay updated. This is not only for the pharma industry, but also for API, cosmetics, biotech, medical devices, R&D, clinical trial material manufacturers, excipients and packaging material manufacturers. Let us also not forget that our Indian regulations too are changing, though at a slower pace.”
Shirgaonkar feels that exports to such demanding markets need competent personnel. This competency or ability comes only from training. Such training builds faith in the minds of the regulator that the organisation is developing people for better quality products.
He adds that a wide gap between academia and industry is also making training institutes important. Pharmacy colleges in India do not mould pharmacists to meet industry requirements. Few companies have GMP training cells or competent staff and the required dedicated time to provide result-oriented training. These are the main drivers for the increasing demand for training which is unlikely to reduce. Based on his estimates, by 2020, the GMP training business itself would be more than ` 2020 crores in the country.
As far as core GMP training institutes are concerned, besides selected training institutes, training activity was mostly carried out by industry associations like Indian Pharmaceutical Association (IPA), Indian Drug Manufacturer’s Association (IDMA) and the like. “Since there is a slowdown as far as the pharma companies in the US and EU are concerned, they are outsourcing to India, China and other countries, i.e. the emerging markets. Hence, additional investments/ expansion plans are being put into place to cater to the training needs of pharma professionals in these markets. Training also needs to be provided to the staff of overseas companies which outsource products from such countries,” opines Shirgaonkar
Types of training
 “The deviation of standards and regulatory guidelines may result in non-compliance.” Rajashri Ojha Founder & Director, Raaj Global Pharma RA Consultants |
Rajashri Ojha, Founder and Director, Raaj Global Pharma RA Consultants, informs that the deviation in standards and regulatory guidelines of different countries may result in non-compliance,and hence results in approval failures and refusal of dossier by Health Authority (HA). It has a negative impact on the company’s image and results in delays in time-to-market. “In most cases, re-working and corrections are required in the documentation which also adds to the delay. To avoid such situations, it is necessary to keep pharma professionals abreast with the latest GMP or regulatory guidelines,” says avers.
She adds, “Development of generic products(Formulations), manufacturing, control, BA/BE studies and registration of drug products into different countries, getting marketing approval as per country-specific requirements and meeting cGMP compliance is a challenge for any company. One should have perfect knowledge about ICH GMP, GLP in the pharma industry and ICH GCP during non-clinical and clinical development phases.”
“A good induction training is like a battle half done,” remarks Shirgaonkar. Making a pharma professional GMP compliant involves courses of different types. He elaborates, “Training topics include GMP and GLP fundamentals, good documentation practices, good distribution practices, hygiene and sanitation as basic training where as advanced training would include topics as validation, deviation management and change control, quality risk management, technology transfer or dosage form specific like aseptic practices and likes. Specialised training would further involve training the GMP trainers and training the GMP auditors. As a part of non-GMP training behavioural (soft skills) training would be an added advantage.” He asserts, “Consistency rather than a knee jerk approach is a key to compliance success.”
In house vs external training
Pharma companies may have an option of providing in-house training. However, going with the latest trend pharma companies are preferring to send their professionals for external training. So, what are the added benefits offered by training institutes?
 “Teaching methodology, explanation based on case-studies, evaluation pattern, availability of subject matter experts are the salient features of an external training programmes.”Anagha Maharao Mng. Director, Institute of Pharmaceutical Management |
“Pharma employees are occupied with their work. So, in-house training may or may not take place in true sense. Effectiveness of in-house training may not be reviewed or monitored periodically. Teaching methodology, explanation based on case-studies, evaluation pattern, availability of subject matter experts are the salient features of external training programme. This gives clear understanding of the topic and helps them in implementation,” says Anagha Maharao, Managing Director, Institute of Pharmaceutical Management.
Shirgaonkar clarifies, “When you mention in-house training, these are of two types. One is conducted by the internal employees of the organisation and second by external faculty who visits the organisation. In the former case, the employee may have to perform training as additional job responsibility and hence cannot concentrate on the job at hand or a training cell would be in place but the skill and expertise may not be comprehensive or total.”
He adds, “Training institutes address different topics, are up-to-date and current and deal with training requirements in a professional manner. A participant / learner-oriented institute does not treat it as a task but focuses on transfer of learning. Secondly, due to participation by various industries the concerns are known and understood with a path in sight. In addition, varied expertise that is not available in-house may be available with training institutes. Having opinions of subject matter experts and commonality of GMP issues becomes an added advantage which may not always be possible with an in-house training.”
Ready for additional expenses?
Recruiting an employee and his subsequent absorption within the company is the process where a pharma company would invest a considerable chunk of money. Moreover, GMP implementation asks for a lot of functional changes which in turn would mean infrastructure-related expenditure. Considering this scenario, will a company stretch its financial resources further to ensure its employees are trained in GMP from external institutes?
“We always maintain if training is expensive, try ignorance,” says Shirgaonkar. In his opinion, there are three categories of pharma companies in our industry. The first category has MNCs and lead players who invest and spend money on training. The second category has medium-sized companies where awareness is on the rise and who are now moving forward in terms of training investments. The third category, small companies, are still not very serious enough and are not really keen to spend money on training.
According to Maharao, one reason why pharma companies may not be keen to spend money on training is because attrition rates are pretty high in the pharma industry. Also, additional time and money allotted to training hampers routine work. However, senior management do get an opportunity to attend seminars and conferences.
“There are so many regulatory changes happening at the international level and those who want to stay afloat on the global map need to upgrade themselves with the latest regulatory changes. As far as Indian pharma companies are concerned, they are members of one of the largest pharma industries in the world. I don’t think they will think twice while spending money to train their employees,” opines Ojha.
Measuring credibility
Pharma training institutes are mushrooming across India. Many of these are run by experienced pharma professionals but this may not always be true. Factors such as type of participants, quality of infrastructure and experience of faculty members/trainers contribute to the perceived standards of an institute.
“As far as we know, there is no authority to accredit training institutes. However, bodies like Indian Society for Training and Development (ISTD) can accredit individual trainers to qualify them,” informs Shirgaonkar.
Ojha opines, “A person or a company who undergoes training programme with any institute builds the credibility/authenticity of respective GMP training institutes.” She adds, “Participant’s satisfaction would automatically endorse the credibility of the training institute. The participants or customer provide feedback after training and also start applying their knowledge in day-to-day work. Their satisfaction is important for any GMP training institute.”
Changing regulatory requirements in the global market have forced pharma companies with global ambitions to modify their functions accordingly. Such a development is significant for the Indian pharma industry as many players are already tapping different global markets. This scenario provides a very good platform for pharma training institutes and pharma companies to work together. Knowledge sharing between these two entities at all levels will only help pharma professionals train better and ensure their companies measure up to the toughest scrutiny. At stake is not only the health of the industry, but also patients across the globe.
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