New Delhi: India will soon overhaul its 76-year old Drugs and Cosmetics Act 1940 and bring in a new, modern legislation to regulate production and consumption pharmaceuticals and other related products.
As a precursor to this, the government is bringing in a separate legislation to regulate a wide range of Medical Devices first and based on its success and acceptance by industry and other stakeholders, the drugs regulation Act will follow, said Mr K L Sharma, joint secretary, Ministry of Health and Family Welfare in Government of India, while delivering a Key Note address at the 10thAnnual US India BioPharma and Healthcare Summit 2016 at Cambridge, Massachusetts, organized by the USA-India Chamber of Commerce.
Mr Sharma said these decisions were taken by the Union Cabinet headed by Prime Minister, Mr Narendra Modi, while discussing the amendments proposed to the omnibus 1940 Drugs Act to make it more contemporary. The Cabinet asked for scrapping of the British-era Act and bring in separate legislations to regulate various areas covered by the Act. The Drugs and Cosmetics Act 1940 was last amended in 2003 with more guidelines. The Modi government wants a total fresh look to this Act.
One there will be enactment of the new legislation to regulate medical devices, a separate Act will be formed to regulate five other related areas: drugs, biological products, stem cell and other emerging therapies, traditional Indian medicine (Ayush) and drug testing laboratories and quality control of medical products.
Mr Sharma said the government has embarked on a modernization drive of the sector and as part of it the medical devices quality management system has been put in place under relevant ISO specifications.
“The government is keen to ensure that the regulatory landscape enables business to be done easily,” Mr Sharma told an big gathering of more than 250 pharmaceutical industry leaders from India and the US who had gathered to discuss ways of delivering affordable innovation through global partnerships at this annual event.
The government has started an ambitious exercise in August 2015 to equip the drug regulatory set up in India’s 36 states and union territories and the central government set up by equipment modernization, hiring of hundreds of regulatory experts, multiple training programmes for existing staff with help from regulators from US and Europe and overall skill upgradation of human resources in the system, Mr Sharma said.
World’s largest drugs quality test study held it India, results to be out soon
The government of India will soon reveal the results of the world’s largest ever study taken up to test the quality of more than 47,000 medical products taken up in 2015.
The results will be revealed in August 2015, said Mr K L Sharma, joint secretary in the Ministry of Health and Family Welfare while speaking at a pharmaceutical conference in Cambridge, USA organized by the USA-India Chamber of Commerce (USAIC).
The drug samples were collected by a mammoth exercise coordinated by the central drugs regulators through the National Institute of Biological and Indian Statistical Institute among other institutions. This is believed to be the largest exercise of its kind in the world.
Credits: This news was first reported by Mr Narayanan Suresh, Chief Operating Officer, Association of Biotechnology Led Enterprises (ABLE).
