Taking a cue from Gujarat’s Forensic Science University, which is the only university across the world, dedicated to forensic and investigative science, the Union Health Ministry has plans to set up a similar higher level academic institution to train manpower to regulate the fast growing pharma sector in the country.
The move also aims to provide job opportunities to graduates from the streams of Pharmacy, Biotechnology, Pharmacology, Microbiology and Science subjects after doing specialisation courses in drug regulatory affairs from this university. The plans to set up the ‘University of Drug Regulation for Medicine’ follows acute shortage of inspectors particularly experts in the Central Drug Standards Control Organisation (CDSCO), the country’s top drug regulator headed by the Drug Controller General of India (DCGI) that is hampering the business plans of the drug makers as well as regulatory work.
The proposed university exclusively aims to ensure regulatory affairs in the drug sector as currently a shortage of experts has put a question mark on the standard of the medicines being produced in the country.
The proposal is in a nascent stage. Initially, we will start with around 50 seats in around ten specialised courses including special drug safety, regulatory sciences, standards of drugs and pharma-covigilance among others offering Masters, PhD and Management degrees.
“Intake of the students will be exclusively for the purpose of regulatory affairs. Candidates passing out from this University will not have to hanker for jobs as they will have ample future opportunities for employment,” the official said.
For instance, the DCGI has an ambitious plan to expand in the next few years when it will require over 25,000 to 30000 drug inspectors and specialists across the country as well in its offices proposed to be opened abroad. At present, the DCGI has just 200 officers handling more than 20,000 applications apart from numerous court cases across the country as well.
What’s worst there are only 900 drug inspectors for the country’s 1.2 billion population to check the drug safety in about 8,000 manufacturing units across the country. Moreover, experts from this institute will be recruited in adverse drug reaction (ADR) monitoring centres being set up in Government and top end private hospitals. The Centre aims to improve patient safety and reduce the risk associated with the use of medicines.
The Health Ministry has already set up 110 centres so far and proposes to expand the number to 500 in the next five years. India has the third largest pharma market in the world by volume and 13th in value, with the total size being about Rs100,000 crore of which exports account for Rs42,000 crore. India is also the biggest producer of generic drugs.