New Delhi: The drug regulator’s proposal to make it mandatory for all employees in pharmaceutical manufacturing facilities to get a skill certification by January next year has triggered concerns in the drugs industry.
Worried about the potential losses and the litigation that the proposal could invite, industry experts, during a meeting with officials in the Drug Controller General of India (DCGI), have asked for a year’s more time for certification of all employees.
Pharma experts warned the proposal will lead to “industrial unrest" because it makes it mandatory for employers to discontinue the services of personnel who are not certified by the government’s Life Sciences Sector Skill Development Council (LSSSDC), a not-for-profit.
Aiming to improve the quality of products manufactured by India’s $30-billion drug industry, the regulator had earlier made it mandatory that, effective January 2018, no person could be employed in any pharmaceutical/bio pharmaceutical manufacturing unit unless they had a formal diploma or degree in the relevant area, or been certified by the LSSSDC or an equivalent organization.
“Keeping in view the objective of bringing substantial improvements in the quality of pharmaceutical products, it has become imperative that all personnel employed in pharmaceutical manufacturing units shall undergo the certification programmes developed by Life Sciences Sector Skill Development Council ," said the notification issued by the central drug standards control organization in August 2016.
The move came after domestic pharma companies faced action from regulatory authorities in the US and Europe due to the quality of products, poor manufacturing facilities and improper documentation.
With the deadline looming, the industry has now approached Drug Controller General of India calling for more time.
According to Indian drug industry experts, “It is not possible for the LSSSDC to certify personnel employed in all pharmaceuticals units for around 57 qualification packs by January 2018, given that LSSSDC is certifying the existing workforce for a few job roles only, like production/manufacturing chemist, production supervisors, manufacturing assistant, production machine operator, maintenance assistance, fitter mechanical, packing supervisor, packing assistant."
Industry experts say that if implemented in its present form, the proposal will have a negative impact on growth and profitability.
“Though we acknowledge the good intent of the government which is aimed at tightening the quality standards, if done in this manner, it will not only result in litigation in the labour courts but will also lead to industrial unrest at all pharmaceutical units. The grievances have been conveyed to the regulator, and we have asked it to shift the deadline, giving the industry an extra one year for implementing the new rule in letter and spirit," said an industry expert, requesting anonymity.