Ahmedabad: The central government may table the Drugs, Medical Devices and Cosmetics Bill2023 in Parliament in the upcoming session, which will replace the pre-independence Drugs and Cosmetics Act, 1940.
Gujarat’s pharma industry, which contributes around 30% nationally, believes that once passed, the law will be at par with international legislations and bring the best global regulatory practices to support the Indian pharma and medical device industry.
It will bring issues like medical devices and clinical trials among others into legal ambit.
Consultations have been held with Gujarat’s drug controllers and industry associations and according to industry sources, the proposes constituting the Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB).
There will be specific provisions for recall of drugs, cosmetics and medical device by the manufacturer and will benefit patients. While import of drugs, cosmetics, medical devices, and clinical trials of new drugs and clinical investigation of new medical devices will be regulated by the central government, states will govern sale and distribution.
Viranchi Shah, president of the Indian Drug Manufacturers’ Association (IDMA) said, “Once enacted, the legislation will promote ease of doing business, decriminalise minor offences and promote upgradation of Indian pharma industry to global quality standards. It will also support Atmanirbhar Bharat in API (active pharma ingredients) and medical devices industries by promoting growth of these segments.”
An association office-bearer said, “Once the bill is passed, the new regulation of drugs, cosmetics and medical devices will ensure their quality, safety and efficacy with proper ecosystem for encouraging the research, development and innovation of new products. Regulation of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) will promote quality of medical products at supply chain level also.”
The bill has provisions for emergency use approval and accelerated approval of new drugs and investigational medical devices besides specific provisions for compensation in condition of injury or death of participant, along with the medical management of such participants in trials. It lists provisions for risk-based classification of medical devices and has norms related to powers to prohibit, restrict and regulation of sale of drugs, cosmetics and medical devices online.
We also published the following articles recently
Gujarat’s pharma industry, which contributes around 30% nationally, believes that once passed, the law will be at par with international legislations and bring the best global regulatory practices to support the Indian pharma and medical device industry.
It will bring issues like medical devices and clinical trials among others into legal ambit.
Consultations have been held with Gujarat’s drug controllers and industry associations and according to industry sources, the proposes constituting the Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB).
There will be specific provisions for recall of drugs, cosmetics and medical device by the manufacturer and will benefit patients. While import of drugs, cosmetics, medical devices, and clinical trials of new drugs and clinical investigation of new medical devices will be regulated by the central government, states will govern sale and distribution.
Viranchi Shah, president of the Indian Drug Manufacturers’ Association (IDMA) said, “Once enacted, the legislation will promote ease of doing business, decriminalise minor offences and promote upgradation of Indian pharma industry to global quality standards. It will also support Atmanirbhar Bharat in API (active pharma ingredients) and medical devices industries by promoting growth of these segments.”
An association office-bearer said, “Once the bill is passed, the new regulation of drugs, cosmetics and medical devices will ensure their quality, safety and efficacy with proper ecosystem for encouraging the research, development and innovation of new products. Regulation of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) will promote quality of medical products at supply chain level also.”
The bill has provisions for emergency use approval and accelerated approval of new drugs and investigational medical devices besides specific provisions for compensation in condition of injury or death of participant, along with the medical management of such participants in trials. It lists provisions for risk-based classification of medical devices and has norms related to powers to prohibit, restrict and regulation of sale of drugs, cosmetics and medical devices online.
We also published the following articles recently
UP CM Yogi reviews Medical Devices Park projects, tells YEIDA to expedite work
UP CM Yogi Adityanath directs officials to accelerate work on 9 projects at UP Medical Devices park in Greater Noida. Progress on construction projects including Lab Mechatronics, Electronic Assembly Facility, Administrative Office Block, export-Promotion Incubation and Excellence Skill Development Incubation Centre. YEIDA initiates commercial hotel plots scheme near Jewar Airport. 3D design and rapid prototyping in Common Tooling Room and Tooling Lab Mechatronics begin. Construction progress on Electronic Assembly Facility, Common Office Showrooms, and Common Office Complex. Significant progress in internet and computer infrastructure. Approval process expedited for Bio-testing Facility and ongoing tender approval for Common IT facilities.
UP CM Yogi Adityanath directs officials to accelerate work on 9 projects at UP Medical Devices park in Greater Noida. Progress on construction projects including Lab Mechatronics, Electronic Assembly Facility, Administrative Office Block, export-Promotion Incubation and Excellence Skill Development Incubation Centre. YEIDA initiates commercial hotel plots scheme near Jewar Airport. 3D design and rapid prototyping in Common Tooling Room and Tooling Lab Mechatronics begin. Construction progress on Electronic Assembly Facility, Common Office Showrooms, and Common Office Complex. Significant progress in internet and computer infrastructure. Approval process expedited for Bio-testing Facility and ongoing tender approval for Common IT facilities.
Rules of origin for medical devices sector remains a sticking point under India-UK proposed FTA
India and the UK are in negotiations to resolve differences in the proposed free-trade agreement (FTA), particularly regarding the rules of origin for the medical devices sector. The Indian market heavily depends on imports for medical devices, with the US, Germany, China, Singapore, and the Netherlands being the top exporters. The government aims to promote domestic manufacturing and attract investment in the sector through initiatives like Medical Device Parks and a production-linked Incentive scheme. However, experts suggest that India should refrain from giving duty concessions and consider relaxations for devices not manufactured domestically.
India and the UK are in negotiations to resolve differences in the proposed free-trade agreement (FTA), particularly regarding the rules of origin for the medical devices sector. The Indian market heavily depends on imports for medical devices, with the US, Germany, China, Singapore, and the Netherlands being the top exporters. The government aims to promote domestic manufacturing and attract investment in the sector through initiatives like Medical Device Parks and a production-linked Incentive scheme. However, experts suggest that India should refrain from giving duty concessions and consider relaxations for devices not manufactured domestically.
Ramanagara, Kanakapura set to get medical colleges
Karnataka is set to have two new government medical colleges at Ramanagara and Kanakapura. These colleges, Ramanagara Institute of Medical Sciences and Kanakapura Institute of Medical Sciences, will have 150 seats each. The decision to establish these colleges comes after the National Medical Commission deferred its plan to limit new colleges based on population. The Rajiv Gandhi University of Health Sciences (RGUHS) has approved the establishment of these colleges and will send the applications to the NMC.
Karnataka is set to have two new government medical colleges at Ramanagara and Kanakapura. These colleges, Ramanagara Institute of Medical Sciences and Kanakapura Institute of Medical Sciences, will have 150 seats each. The decision to establish these colleges comes after the National Medical Commission deferred its plan to limit new colleges based on population. The Rajiv Gandhi University of Health Sciences (RGUHS) has approved the establishment of these colleges and will send the applications to the NMC.
