Drugs and Cosmetics (D&C) Rules amendment to make submission mandatory
The Central Drugs Standard Control Organisation’s (CDSCO) bid to create India’s first national digital database for pharmaceuticals has got a shot in the arm with the Drugs Technical Advisory Board (DTAB) agreeing to the proposal to make a declaration mechanism mandatory for all firms licensed to manufacture medicines in India. The apex drug advisory body on technical matters has also backed amendments to the Drugs and Cosmetics (D&C) Rules of 1945 to bring the initiative to fruition, it is learnt.
The central regulator aims at making it mandatory for all drug makers to upload the details of their manufacturing licenses and list of products on ‘Sugam’, an online portal developed by the health ministry. The state licensing authorities can easily verify it by checking the inputs on the site. Once it is made mandatory, all the manufacturers will be putting details of their facilities and products regularly in the database.
The central regulator aims at making it mandatory for all drug makers to upload the details of their manufacturing licenses and list of products on ‘Sugam’, an online portal developed by the health ministry. The state licensing authorities can easily verify it by checking the inputs on the site. Once it is made mandatory, all the manufacturers will be putting details of their facilities and products regularly in the database.
“At present, India doesn’t have comprehensive information on domestic drug manufacturing industry and the CDSCO has to bank on data obtained from state authorities. And many a time, the state officials are helpless in providing specific real-time data. The ‘Sugam’ portal can resolve this issue to a great extent if the current self-declaration clause is made mandatory,” an industry lobby group representative opined.
The database would come in handy for the drug manufacturers and consumers alike as it provides details of licenses issued for manufacturing sites and drug formulations by state FDAs along with a list of approved wholesalers and retailers. The move is the latest in a slew of measures adopted by the CDSCO to boost ease of doing business in the country. The Drug Controller General of India has recently opened a public relations office at the CDSCO headquarters which can be approached by innovators and start-ups seeking information regarding regulatory requirements for commercialisation of products.
It may be noted that the Union health ministry has been striving to digitise information key to healthcare to enable interoperability and exchange of data in the country. The government has recently finalised the draft of the proposed digital information security in healthcare act (disha) to establish a nodal agency for creating regulatory framework for digital healthcare data. The government is getting ready to set up the statutory body through an Act of Parliament. The authority will play a key role in promoting e-health standards by enforcing privacy and security measures and regulating storage and exchange of records. The Act will also pave the way for the setting up of Health Information Exchanges. “With an all-encompassing digital data on domestic drug manufacturing and healthcare in hand, it will be easier for the government to limit or boost the production of a particular drug to tackle shortage or oversupply,” the industry representative added.
Indian pharma sector is estimated to account for 3.6 per cent of the global pharmaceutical industry in value terms and 10 per cent in volume terms. It is expected to grow to $100 billion by 2025. According to official estimates, the sector would generate 58,000 additional job opportunities by the year 2025.
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Mr. Pralhad Jadhav
Master of Library & Information Science (NET Qualified)
Senior Manager @ Knowledge Repository
Khaitan & Co
Twitter Handle | @Pralhad161978
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