Clinical Research Organisation Bangalore

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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Chronic Pain Could Have a Unique Genetic Basis in Women

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A sweeping meta-analysis of data from the United Kingdom Biobank has found a different genetic basis for chronic pain in women compared to men.

The results are still preliminary, but to date, this is one of the largest genetic studies on chronic pain to analyze the female and male sex separately.

“Our study highlights the importance of considering sex as a biological variable and showed subtle but interesting sex differences in the genetics of chronic pain,” says population geneticist Keira Johnston from the University of Glasgow in Scotland.

Chronic pain conditions are among the most prevalent, disabling, and expensive conditions in public health. In the United States, chronic pain affects more people than heart disease, diabetes, and cancer combined, and yet it receives a fraction of the overall funding

Even when studies are done, they often overlook underlying sex differences, and that’s a huge and detrimental oversight. Compared to men, women are far more likely to develop multiple chronic pain disorders, and yet historically, 80 percent of all pain studies have been conducted on male mice or male humans. This means we know very little about how and why females are suffering more and what treatments can help them best.

While there are probably multiple biological and psychosocial processes in this sex discrepancy, the current genome-wide study suggests there’s a genetic factor in the mix, too.

Comparing gene variants associated with chronic pain in 209,093 women and 178,556 men from the UK Biobank, researchers have attempted to find at least part of the answer in our biology.

In the end, researchers found 31 genes associated with chronic pain in women and 37 genes associated with chronic pain in men with barely any overlap. The authors admit some of the differences here might stem from their lower male sample size, but the results are nonetheless intriguing. 

When researchers tested the expression of all these genetic variants across various tissues from mice and humans, they noticed the vast majority were active in a cluster of nerves within the spinal cord, known as the dorsal root ganglion, which transmits messages from the body to the brain.

Several genes in the male-only or female-only list were associated with psychiatric issues or immune function, but only one gene, known as DCC, was in both lists.

DCC encodes for a receptor that binds with a protein crucial for the development of the nervous system, especially the dopaminergic system; as well as being a reward center, the latter has recently been connected to pain modulation in the body.

DCC is also thought to be a risk gene for the pathology of depression, and DCC mutations appear in those with congenital mirror movement disorder, which results in movements on one side of the body being replicated on the other side.

How exactly DCC is connected to chronic pain remains unclear, but the authors say their results support several theories “of strong nervous system and immune involvement in chronic pain in both sexes”, which they hope will be used to develop better treatments in the future.

If chronic pain is more strongly associated with immune function in women, for instance, the side-effects of immune-targeting drugs may be very different to men. On the other hand, treatments such as chronic opioid use might also have different outcomes. Opioids are known to adversely affect immune function, which suggests they could make things worse and not better for women in chronic pain.

For right now at least, these are just ideas. Way more pain research needs to be done and far more of it needs to be conducted among women before we can really begin to understand the real sex discrepancies at play and what we can do about it.

“All of these lines of evidence, together, suggest putative central and peripheral neuronal roles for some of these genes, many of which have not been historically well studied in the field of chronic pain,” the authors conclude.

The study was published in PLOS Genetics.

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DCGI directs SLAs to monitor availability of remdesivir injections & prevent its hoarding

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The Drugs Controller General of India (DCGI) has directed all State Licensing Authorities (SLAs) to monitor availability of remdesivir injections to ensure its supply and also take timely action to prevent its hoarding and black marketing.

“It has been brought to the notice of union health ministry that in Mumbai and Thane region in the state of Maharashtra, Bhopal, Indore and Gwalior in the state of Madhya Pradesh and Ahmedabad, Surat and Rajkot in the state of Gujarat are reporting shortage of remdesivir injections. In view of the same, SLAs are supposed to initiate immediate remedial action to ensure supply of remdesivir injections to public and private hospitals,” the DCGI said in his directive to the SLAs.

SLAs are also requested to instruct the enforcement staff to keep continuous monitoring on the situation and keep strict vigil to ensure availability of remdesivir and also prevent its hoarding and black marketing. Action taken in the matter may be intimated to the DCGI office at the earliest, the DCGI notice further stated.

To curb hoarding and black marketing of remdesivir injection, the Maharashtra Food and Drug Administration (FDA) has recently directed Covid-19 drug remdesivir manufacturers to reduce the wholesale price of the drug and has also proposed to the National Pharmaceutical Pricing Authority (NPPA) to bring it under price control.

Maharashtra FDA Commissioner held a meeting with senior officials at Mumbai headquarters recently to discuss how to reduce this huge gap between the wholesale selling price and MRP of remedesivir injection and how to make this drug available to the patients at reasonable rates.

The Maharashtra FDA is regularly reviewing the availability of remdesivir injection and other drugs in the state. Currently, there are 6 major manufacturers of remdesivir injection 100 mg available in the market.

Based on the review, Maharashtra FDA found out that the maximum retail price of remdesivir manufactured by respective manufacturers like Cipla is Rs. 4,000, Zydus Healthcare is Rs. 2,800, Hetero Healthcare is Rs. 5,400, Dr. Reddy’s Lab is Rs. 5,400, Mylan is Rs. 4,800 and Jubilant is Rs. 4,700.

However, it has been found that the drug was supplied to wholesalers and hospitals at a price of Rs. 800 to Rs. 1,200. In this case, there is an outcry from various quarters about the financial burden being imposed on the patient by the increased maximum retail price (MRP).

Rajendra Shingane, Maharashtra FDA Minister and Saurabh Vijay, secretary, department of medical education and drugs, Maharashtra had also directed to take action in this regard.

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