AHC CRO

Regulators stress on need to strengthen enforcement of MDR to provide clarity on clinical data

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Finding that there are lapses on the part of enforcement officials in every state to enforce the Medical Devices Rules (MDR), regulatory officers under central and state governments have jointly proposed that enforcement of MDR has to be strengthened at state and central levels.

According to the regulators, enforcement will provide an increased clarity on the requirements for clinical data of medical devices, particularly those of high risk patients.

Officers in services and ex services have come to a common online platform to specify their views on “An overview of Medical Devices Regulations in India”, organized by the south zone committee of the Indian Pharmacy Graduates Association (IPGA).

Putting forward the subject for discussion, G Koteswara Rao, coordinator of IPGA south zone clarified that the subject of medical devices regulation deals with rules and regulations which are primarily concerned with enabling patient access to high quality, safe and effective medical devices. One important fact of the regulation is that it ensures benefits to the patients as well as to the health workers. Further, it will help improve the mechanism of clinical data assessment. With proper implementation of the regulations, government can ensure better healthcare and safety to the patients as well as to the general public including all healthcare workers.

Dr Atul Kumar Nasa, drugs controller under Delhi government was the chief guest in the virtual conference. By giving an overview of the latest medical technologies, Nasa wanted the state office-bearers to assist the state regulatory agencies to strengthen the enforcement of the rules. He further wanted the association leaders to improve the membership drive of IPGA in all the states. He is the president of the national committee of the IPGA.

Dr. S Eswara Reddy, Joint Drugs Controller at the Central Drugs Standards Control Organization (CDSCO), New Delhi, was the main speaker at the webinar. The speakers in the webinar said Dr Eswara Reddy was instrumental in bringing up the medical devices rules in India. He presented a crystal clear presentation about the rules and regulations through online. Dr Reddy explained in detail the various categories and classifications of medical devices, how and why they are classified into different categories and which items need licences. He also answered the queries of the webinar participants about licence validity and testing of medical devices.

Dr BR Jagashetty, chief advisor to Karnataka IPGA, Pawan Jaggi, editor in chief of the bulletin IPGA-Today, Dr. Arun Garg, general secretary of the national committee, S. Rajender Reddy, honorary president, IPGA Telangana, N. Narayana Swamy, president, IPGA Tamil Nadu, PM Jayan, general secretary, Kerala IPGA, A.Vijay Bhasker Reddy, president, IPGA-AP and Dr C S Satheesh Kumar, president, IPGA Kerala spoke on the subject. Dr. MC Nishith, EC member of IPGA Kerala, was the moderator of the program.

Members of IPGA branches from Kerala, Karnataka, Tamil Nadu, Andhra Pradesh, Pondicherry and Telangana attended the seminar. E-certificates were issued to all the participants. The programme ended with vote of thanks by Sanju Dhavan, women coordinator of IPGA South Zone.

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Ayush ministry launches nationwide distribution campaign of Ayush 64 and Kabasura Kudineer

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The Union Ministry of Ayush has launched a massive nationwide campaign to distribute its proven poly herbal ayurvadic drugs Ayush 64 and Siddha drug Kabasura Kudineer for the benefit of the vast majority of out of hospital Covid-19 patients. The efficacy of these drugs has been proved through robust multi-centre clinical trials.

The multi stakeholder campaign being launched by Ayush minister, Kiren Rijiju, (additional charge) will ensure that medicines reach the needy in a transparent and efficient manner. The main collaborator in the campaign is Sewa Bharati.

The Ministry of Ayush-Council of Scientific and Industrial Research (CSIR) collaboration has recently completed a robust multi-centre clinical trial to evaluate the safety and efficacy of Ayush 64 in the management of mild to moderate Covid-19 patients. Kabasura Kudineer, a Siddha medicine was also subjected to clinical trials for studying the efficacy in Covid-19 patients by Central Council for Research in Siddha (CCRS) under Ministry of Ayush and is also found useful in the treatment of mild to moderate Covid-19 infection.

The Ayush ministry has taken several initiatives toward control and mitigation of Covid-19, while also working in close collaboration with Union ministry of health & family welfare in the fight against Covid-19. With the latest initiative of the ministry to launch a nationwide campaign for distribution of Ayush 64 and Kabasura Kudineer, India aims to strengthen its position in fight against Covid-19, said the statement issued by the Ayush ministry.

Many clinical and observational studies have been undertaken to understand the role of Ayush interventions in mitigation and management of Covid-19 whereas various studies were carried out on Ayush 64, an ayurvedic formulation developed by the Central Council for Research in Ayurvedic Sciences (CCRAS) and Kabasura Kudineer, a classical Siddha formulation, it further stated.

The Ayush 64 is recommended in National Clinical Management Protocol based on Ayurveda and Yoga which is vetted by National Task Force on Covid-19 Management of Indian Council of Medical Research (ICMR).

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DCGI approves anti-Covid drug 2-DG developed by DRDO and DRL for emergency use

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The Drugs Controller General of India (DCGI) has approved anti-Covid drug 2-deoxy-D-glucose (2-DG) for emergency use.

The drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

The drug comes in powder form in sachet, which is taken orally by dissolving it in water. It accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.

Clinical trial results have shown that this molecule helps in faster recovery of Covid-19 hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients. The drug will be of immense benefit to the people suffering from Covid-19.

In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, DCGI permitted phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.

The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients. In phase-II trials (including dose ranging) conducted during May to October 2020, the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery. Phase IIa was conducted in six hospitals and phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.

In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC.

Based on successful results, DCGI further permitted the phase-III clinical trials in November 2020. The phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 Covid hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-III clinical trials was presented to DCGI.

In the 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by day-3 in comparison to SoC, indicating an early relief from oxygen therapy/dependence.

The similar trend was observed in patients aged more than 65 years. On May 01, 2021, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe Covid-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.

In the ongoing second Covid-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation. The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of Covid-19 patients.

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