New Delhi: The Central government has released more than 80 per cent of the funds allocated as Central share for the strengthening of drug regulatory system across the States including strengthening of the testing infrastructure and upgradation of existing offices.
As part of strengthening the drug regulatory system in the country, both at the Central and state level, the Centre has approved Rs. 1,750 crore, of which Rs. 900 crore was for strengthening the Central drug regulatory structures and Rs. 850 crore was for the Central sponsored scheme of ‘Strengthening of States’ Drug Regulatory System (SSDRS).
The Centre has so far released funds to the tune of Rs. 699.28 crore as part of the Central share under the SSDRS Scheme, said Union health minister J P Nadda recently. In a statement submitted in the Lok Sabha earlier this month, he added that this was one of the several actions taken by the Centre to strengthen the drug regulatory mechanism and ensure quality of drugs produced in the country.
According to the Ministry, the Cabinet Committee on Economic Affairs, chaired by the Prime Minister Narendra Modi, in August 2015, approved the proposal for SSDRS with an aim to strengthen and upgrade the system, and the funds were to be made available to the State governments after signing a Memorandum of Understanding.
The up-gradation envisaged to include provision of additional equipment and manpower in existing drug testing laboratories; setting up of new laboratories for testing drugs, medical devices and cosmetics; making mobile drug testing laboratories available; creation of additional manpower for regulatory structures, including for new and emerging areas such as stem cell, regenerative medicine, biologicals and medical devices in addition to drugs.
It was also aimed to introduce organisation-wide e-Governance and Information Technology enabled/online services, and setting up a training academy for regulatory and drug testing officials, of both the Central and state governments.
“Assistance will be provided to the States for strengthening their drug regulatory structures. The measure will help enhance quality, safety and efficacy of drugs and other medical products manufactured in the country, and thereby help mitigate the disease burden as also increase export of pharmaceutical products from India. Besides, it will also help trigger growth of the domestic medical devices sector,” said the Ministry in 2015.
In tune with the aim to upgrade the drug regulatory mechanism, the Central government has also conducted 22 training programmes for Central Drugs Standard Control Organisation (CDSCO) and State Drug Control Officials in the financial year 2023-24, said Nadda earlier this month.
The Indian pharmaceutical industry is the third largest by volume and 13th largest by value in the world, producing more than 60,000 generic drugs across 60 therapeutic categories. The Centre has taken several steps including amendment of the Drugs Rules to revise the Schedule M for Good Manufacturing Practices and implementation of bar code or Quick Response Code on the primary packaging label of top 300 brands, among others, to ensure the quality of products manufactured in the country, he added.
