PSM News

August 24,2024 Mumbai: A 14-bed ward has been reserved at Seven Hills Hospital in Maharashtra’s Mumbai as a precautionary measure regarding Monkeypox infection. There is no single case of monkeypox in the Mumbai metropolitan area, however, measures were taken by the Brihanmumbai Municipal Corporation (BMC) as directed by the government. The Public Health Department of Brihanmumbai Municipal Corporation has been coordinating with the Health Information Room of the International Airport. The cases of monkeypox have been reported in Pakistan and Sweden. Considering the number of foreign visitors in the Mumbai metropolis, more precautions have been taken. No case of ‘monkeypox’ infection has been reported in the Brihanmumbai Municipal Corporation area yet. Speaking to ANI, Assistant Medical Superintendent Dr Pradnya Pawar said, “We have set up 14 isolation beds. We have dedicated this ward to monkeypox. We also have an ICU for monkeypox. If a monkeypox suspect with serious complications comes in, we will admit him/her there. In India, we have not seen any cases but it is assumed that there can be cases. The main symptoms are rashes, fever, cough, and soar throat. A monkeypox patient can have asymptomatic symptoms.” Earlier on, former Chief Minister of Maharashtra, Prithviraj Chavan, has called for proactive measures to implement testing and quarantine facilities at Mumbai Airport in response to the global spread of the monkeypox (Mpox) virus. In a letter to the state’s Chief Minister, Eknath Shinde, Chavan recommended the immediate implementation of testing and quarantine facilities at Mumbai Airport for passengers arriving from high-incidence countries, a measure that was inadequately enforced during the COVID-19 pandemic. The World Health Organisation (WHO) declared Mpox a public health emergency of international concern. This decision comes amid a rapid surge in the spread of the disease in the Eastern Democratic Republic of Congo (DRC) and its detection in neighbouring countries. Pakistan’s federal health ministry confirmed the country’s first Mpox case. On August 16, the Khyber-Pakhtunkhwa (K-P) health department confirmed two more Mpox cases in the province, as reported by the Express Tribune. The Swedish government also confirmed its first case of Mpox, marking the first case of the variant outside Africa, according to Al Jazeera. Source: Healthworld

August 24,2024 New Delhi: Following the recent ban on 156 drugs, the Government of India is now considering banning 34 additional multivitamins, according to sources. “34 multivitamins are under evaluation based on reviews,” sources said. The sources also mentioned that under new regulations, states can no longer approve drug combinations. “Based on the recommendations of the DTAB sub-committee, the Central Government recently prohibited 156 Fixed-Dose Combinations (FDCs),” sources added. “As per the first assessment report of the Professor Kokate committee, constituted by the Central Government to examine FDCs licensed by state authorities without the permission of the Drug Controller General of India (DCGI), several FDCs were declared irrational. However, these notifications were challenged in court, and the matter was referred to the DTAB,” sources said. Sources indicated that these drugs are banned based on concerns about safety and efficacy. The Indian Pharmaceutical Alliance (IPA) has endorsed the government’s decision. Sudarshan Jain, Secretary General of the IPA, told ANI, “This has been ongoing for many years, with committees such as the Kokate Committee and the Nilima Kshirsagar Committee reviewing the matter extensively. This is a right step taken in the interest of patients, considering all aspects.” When asked about the impact on pharmaceutical companies, Jain said, “They have been given the opportunity to provide data supporting their products. Those with adequate supporting data will continue, while companies lacking such data will have to withdraw their products.” The list of banned drugs includes medications used for hair treatments, antiparasitic purposes, skincare, and anti-allergic treatments. These medicines are fixed-dose combination (FDC) drugs, also known as cocktail drugs, which combine more than one drug into a single pill. According to a Gazette notification issued by the government announcing the ban, “The matter was examined by an Expert Committee appointed by the Central Government, which reviewed the entire issue thoroughly and deemed these FDCs irrational. The Drugs Technical Advisory Board also examined these FDCs and recommended that there is no therapeutic justification for the ingredients contained in them, and they may pose risks to human beings.” The notification further stated, “In the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of these FDCs under Section 26A of the Drugs and Cosmetics Act, 1940. Based on the recommendations of the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture for sale, sale, and distribution for human use of the said drugs in the country.” Among the banned combinations is the FDC of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain, which has been prohibited with immediate effect. Mefenamic Acid + Paracetamol Injection is likely to pose a risk to human beings and is also prohibited. Additionally, Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate has also been prohibited with immediate effect. Source: Healthworld

August 24,2024 New Delhi: The health insurance sector may face challenges in the coming months due to rising claims and increased competition, particularly in the retail sector, highlighted a report by Jefferies. “Health (approx. 35 per cent of mix) can see pressure in its retail segment from rising claims frequency and elevated competition” the report stated. The report indicated that India’s non-life insurance sector is experiencing significant shifts, the health insurance segment may face challenges as healthcare costs continue to rise and more consumers claim their insurance, and insurers are grappling with increased payouts. This trend could squeeze margins and put pressure on insurers to find ways to manage costs while remaining competitive in the market. However, for the motor insurance segment, the report draws a promising picture and added that it is entering a promising multi-year upcycle. This positive momentum is expected to benefit large private insurers of the motor segment, who are well-positioned to capitalise on these trends. “Initiate on Non-Life Insurers Large pvt. insurers are set to gain from multi-year upcycle in motor (approx. 35 per cent of premium mix) led by premiumisation of underlying auto mix and moderating competitive intensity” the report mentioned. The report also added that the motor insurance segment in India is estimated to grow at a compound annual growth rate (CAGR) of 14 per cent over the financial years 2024 to 2027. The key driver behind this growth is the ongoing shift in the automobile market towards higher-value vehicles. Over the past three years, the average selling price (ASP) of passenger vehicles (PVs) has increased by 41 per cent, reflecting a move towards premium segments. This trend is expected to continue, benefiting motor insurance renewals, which account for 60-70 per cent of the motor insurance premium mix. “Motor segment amidst a multi-year upcycle (est. 14 pc CAGR over FY24-27E) as renewals (60-70 pc of premium mix) will continue to benefit from the underlying change in auto mix towards premium high-value segments (ASP of PV up +41pc in last 3 yrs)” the report added. Despite these challenges, the report mentioned that the broader non-life insurance market in India remains significantly underpenetrated, with insurance premiums representing only about 1 per cent of the country’s GDP. This is relatively low compared to global peers, where non-life insurance to GDP ratios range between 2 per cent and 4 per cent. However, the Indian non-life insurance market has shown steady growth, with gross premiums expanding at a CAGR of 12 per cent over the past five years, reaching Rs 2.8 trillion (approximately USD 35 billion). Notably, the private sector has outpaced the overall market. “India remains an under-penetrated market with non-life insurance to GDP at approx. 1 pc (vs 2-4 pc for global peers). Gross premiums have expanded at 12 pc CAGR over the last 5 years to Rs2.8tn (approx. USD 35bn) with the private sector growing faster at 15 pc CAGR and improving its market share to 68 pc (from 57 pc)” said Jefferies in the report. Despite these challenges, the overall insurance market in India remains underpenetrated, offering significant long-term growth potential for insurers who can navigate these dynamics effectively. Source: Healthworld

August 26,2024 New Delhi: The Union Cabinet, chaired by Prime Minister Narendra Modi, approved the BioE3 policy–Biotechnology for Economy, Environment, and Employment–aimed at fostering high-performance biomanufacturing, on Saturday. The policy is designed to supplement, rather than replace, traditional supply methods with biotechnological solutions to meet the demands of a developed India by 2047. “Industrial revolutions have historically transformed human activities, and the coming years present an opportune moment for the industrialisation of biology. It is crucial to adopt new technologies to drive GDP growth, create new employment opportunities, and benefit the environment. The BioE3 policy is a forward-looking initiative that positions India as a potential global leader in this next revolution,” officials stated on Sunday. The policy will accelerate technological development and commercialisation by establishing biomanufacturing facilities, bio-AI hubs, and biofoundries. On the social media platform X, the Department of Biotechnology highlighted the policy’s innovative approach. “High-performance biomanufacturing can fundamentally transform the global economy from today’s consumptive and unsustainable manufacturing paradigm to one based on regenerative principles,” the department stated. Government data reveals that between 1950 and 2021, 8.7 billion tonnes of plastic were produced, with only 11 percent recycled. This policy aims to introduce more sophisticated recycling processes, smarter materials, and biomanufacturing techniques to reimagine the future and address challenges in food, climate, energy, chemicals, and health. The policy outlines three implementation strategies: discovery and integrated research networks, bridging existing gaps, and establishing bio-enabler hubs. The policy envisions a future that is more sustainable, innovative, and responsive to global challenges like climate change, unsustainable material consumption, and waste generation. It also aims to revolutionise the production of everything from medicines to biomaterials. “Broadly, the policy will also support the development of an integrated chemical and biological platform for the on-demand production of nutritious, palatable, and safe food from minimal resources, benefiting disaster relief efforts and space exploration,” officials added. A top source informed that 21 ministries have approved the policy, which is expected to take shape by December of this year. Additionally, over 8,000 biotechnological startups will be involved, generating more job opportunities, contributing to GDP growth, and promoting sustainability. (ANI) Source: Pharma

August 26,2024 Thiruvananthapuram: Health minister Veena George has said that the Centre has sanctioned Rs 69.35cr under the National Health Mission (2024-25) for the development activities of healthcare institutions in the state. She said more projects have been approved, including construction work worth Rs 69.35L to upgrade infrastructure of healthcare institutions. Approval has been given for the development activities of 29 healthcare institutions, she said. These include Rs 6.16cr for the construction of a 50-bed mother and childcare centre at Kanjirappally General Hospital in Kottayam; Rs 4.70cr each for constructing warehouses in Kollam and Kozhikode; Rs 4.5cr for building new OP and IP blocks at Tata Hospital in Kasaragod; Rs 3.33cr for a skill lab and training centre in Malappuram; and Rs 3.87cr for renovating the OP block and casualty at Palluruthy Taluk Hospital. Additionally, Rs 3cr has been approved for strengthening the diagnostic block at Pathanamthitta General Hospital; Rs 1.70cr for constructing staff quarters at Edamalakudy in Idukki; and Rs 3cr to enhance the gynaecology department at Idukki District Hospital. As much as Rs 1.50cr is allocated for the paediatric ward at Perinthalmanna District Hospital in Malappuram and for strengthening the IP block at Vythiri Hospital in Wayanad; Rs 2.10cr for the casualty block at Pazhayangadi Hospital in Kannur; and Rs 3.11cr for renovating the operation theatre at Kanhangad District Hospital in Kasaragod. George said these projects are in addition to the ongoing development activities in hospitals. Source: Healthworld

August 14,2024 New Delhi: The Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated the Phase 3 clinical trial for DengiAll, an indigenous tetravalent dengue vaccine developed in India. This trial marks a significant milestone in the nation’s efforts to combat dengue, a disease for which no antiviral treatment or licensed vaccine currently exists in the country. The Phase 3 trial will be conducted at 19 sites across 18 States and Union Territories, involving more than 10,335 healthy adult participants. The participants will be followed for two years, with the first vaccination administered at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak. The challenge in developing an effective dengue vaccine lies in achieving good efficacy against all four serotypes of the virus, which are known to circulate or co-circulate in many regions. The successful development of this vaccine could have a profound impact on public health in India. Speaking about the indigenous dengue vaccine, Union Minister of Health & Family Welfare, J.P. Nadda, said, “The initiation of this Phase 3 clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue. Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector.” The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the NIH, has shown promising results worldwide, and the Indian formulation’s earlier trials in 2018-19 further strengthen the hope for a successful outcome in this critical Phase 3 trial. Source: Pharma

August 13,2024 In less than a week since the Drugs Controller General of India (DCGI) has given permission to pharma companies to launch certain types of drugs without local clinical trials, the economic think tank GTRI (Global Trade Research Initiative) has opposed the decision. GTRI has said that the decision is going to adversely impact the patients in India and could hurt the domestic pharma industry. “By overlooking India’s unique genetic diversity, the waiver could lead to unexpected safety and effectiveness issues. Also, it might increase competition from multinational corporations making it harder for local pharma companies and contract research organisations (CROs) to grow,” GTRI said in a statement. As per the think tank, the genetic make-up of Indians are different from the US and EU who have diverse population, and therefore, it’s essential to do local trials to ensure that new drugs are both safe and effective for Indian patients. The DGCI has exempted the local clinical trials across five categories of new drugs, including drugs for rare diseases, gene and cell therapies, pandemic-related treatments, and those with significant therapeutic advances. GTRI said that many of these drugs are developed quickly, and are experimental. “Some companies get approval abroad but choose not to sell these drugs there due to concerns about patent protection and potential compensation if something goes wrong. Instead, they focus on countries with weaker regulations like India. We must exercise caution as many such drugs can lead to serious and sometimes dangerous outcomes,” GTRI said. Meanwhile, pharma association said that even though the companies are not required to do phase 3 trials now, they will still have to conduct post-marketing surveillance studies across thousands of patients. “While phase 3 trials are no longer required for certain new drugs, the companies will still have to conduct phase 4 studies which happens after the product launches,” said Anil Matai, director general, Organisation of Pharmaceutical Producers of India (OPPI). Further, GTRI said that the waiver could affect local firms and CROs at the cost of MNC pharma companies.  “The reduction in the number of clinical trials could hinder the growth of over 250 local CROs. MNCs have argued that clinical trials in India were too expensive even though they cost much less than in the US. This (waiver) benefits MNCs by reducing costs and time, allowing them to launch new drugs faster. They also avoid the risk of compensation and liability if something goes wrong during trials,” said GTRI. Source: Financial Express

July 30,2024 Five out of 12 Centres of Excellence (COEs) formed to treat patients suffering from rare diseases have utilised less than 35 per cent of the funds allotted to them by the Centre over the last three years, according to patient advocacy groups and data from a reply given in Parliament.   According to data accessed by Business Standard, the maximum fund utilisation was seen at Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata at 93.65 per cent. The next in the chart was King Edward Medical Hospital, Mumbai at 93.55 per cent. Hyderabad-based Centre for DNA Fingerprinting & Diagnostics with Nizam’s Institute of Medical Sciences stands last in the list with only 4.53 per cent funds utilisation. Followed by Delhi’s Maulana Azad Medical College at 17.62 per cent. According to a reply given by the health ministry in Parliament, as of February this year these centres have utilised only 48% of around Rs 109 crore disbursed in the last three years. COEs are institutions identified by the central government to actively treat patients suffering from rare diseases. Currently, 12 such centres have a quota of 2,420 rare disease patients from six categories across three groups.  “While the government has set up CoEs to treat patients with rare diseases, patients with Group 3a conditions are still experiencing inordinate delay in procedural formalities across these centres,” a member associated with an advocacy group for patients with Group 3a conditions said.   According to the rare disease policy enacted in 2021, Group 3a includes conditions such as Lysosomal Storage Disorders (LSD’s) for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost, and lifelong therapy.  “There are currently around 454 eligible rare disease patients with LSD’s such as Pompe disease, Fabry disease, Mucopolysaccharidosis (MPS) type I and type II in India, to be put on immediate life-saving therapy as per the National Policy for Rare Diseases 2021,” the member added.  Source: Business Standard

August 13,2024 The Central Drugs Standard Control Organization (CDSCO) has directed makers of sterile equipment to comply with Schedule M of the Drugs and Cosmetic Rule, which mandates companies to follow Good Manufacturing Practices (GMP) at par with the World Health Organization (WHO) standards. Till now, GMP has been compulsory for only drug makers but compliance is regarded as equally important for sterile product and vaccines makers. The development assumes significance given the growing size of the Indian sterile equipment market.  “The revised GMP notification which was published last December is generally for all types of pharmaceutical items. It prescribes general requirements that need to be followed by all the pharmaceutical firms. The notification clearly specifies the requirements for each type of product such as sterile products, biologicals, ophthalmic solutions and other injectables etc.,” said an official. “In addition to the general requirements, WHO publishes their guidelines from time to time for various products. Companies have been told to do the self-assessment, take necessary steps to fill the gaps and strengthen GMP compliance as per WHO standards,” said the official mentioned above. These products include surgical equipment, forceps, biopsy equipment, eye equipment including soft contact lenses, eye solutions, arthroscopes, and laparoscopes and injectables which directly goes into the bloodstream of the patient. Good Manufacturing Practices, or GMP, as mandated by the WHO, prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, and the environment. The government, last year in December, had amended or revised the Schedule M of the Drugs and Cosmetics Rules, 1945 to upgrade, tighten and make GMP norms mandatory, especially for micro, small and medium enterprises (MSMEs). As part of the government’s guidelines, which were announced in July 2023 and notified in December 2023, pharma companies with annual turnovers of over ₹250 crore were to compulsorily follow GMP within six months, while those with a turnover of less than ₹250 crore were supposed to do so over a 12-month period. Compliance of GMP guidelines was made stronger to ensure the quality standards of drugs being manufactured in India after the Central government’s risk-based inspection of pharmaceutical firms found serious lapses at the manufacturing site such as infrastructural deficiencies, poor documentation, under-skilled employees, absence of testing of raw material etc. This was done in the backdrop of Indian cough syrups causing the deaths of children in Gambia and Uzbekistan. “This is with reference to revision of schedule M and WHO good manufacturing practices for sterile pharmaceutical products, which are published by WHO from time to time. In this regard, it is requested that all manufacturers should take necessary steps for compliance with respect to various requirements as per the guidelines after due gap analysis,” said DCGI in a communication on 7 August to all sterile and vaccine manufacturers. Aniket Dani, Director-Research, CRISIL Market Intelligence & Analytics said, “As per the latest available data, the domestic vaccines market size stood at about Rs. 1,700 crore for fiscal year 2024. This segment contributed about 1% of the overall domestic formulations market.” Rajiv Nath, Forum Coordinator of AiMeD (Association of Indian Medical Devices Industry) said that the market for medical sterile medical devices may be over $ 4-5 billion. Meanwhile, the government is continuously conducting risk-based assessment of these pharmaceutical companies Health minister J.P. Nadda recently stated in Parliament that in the last one year the government had conducted risk-based inspections of 400 pharma companies to check if they are following GMP rules. As a part of the inspection, more than 300 show cause notices, stop production order, suspension, cancellation of licences have been issued. Source: Drugs Control

August 12,2024 The Drugs Controller General of India (DCGI), the country’s top drug regulator, has framed standard operating procedure and guidelines to ensure product traceability throughout the supply chain, as the menace of fake and spurious medicines grows. The DCGI has circulated this good-distribution practice as traceability is a big challenge due to a lack of proper documentation throughout the distribution channel. The development assumes significance as the Indian pharmaceutical industry has come under global glare following allegations that spurious cough syrups from the country were linked to children’s deaths in Gambia, Cameroon, and Uzbekistan. In the recent DCGI’s drugs consultative committee meeting held in June, it was decided to incorporate good distribution practice as a Schedule in the Drugs and Cosmetic Rule, 1945. It was discussed that due to the non-mandatory nature of guidelines, the maintenance of storage conditions of drugs during the transit till wholesale and retail level was not ensured by the manufacturers. These draft guidelines on good distribution practice have been framed at par with World Health Organization standards and stakeholders can send in their comments and suggestions over the next 30 days, before the rules are finalized. Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945 specify the conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute the drugs across the country. The draft guidelines said that individuals such as manufacturers and wholesalers, brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees are generally responsible for the handling, storage and distribution of pharma products. Therefore, to maintain the original quality of pharmaceutical products, every party involved, such as in the distribution chain, must comply with the standards of good distribution practice. “Substandard and spurious products are a significant threat to public health and safety. This guideline is meant for those involved in the supply chain of medical items and their active role to protect the pharmaceutical supply chain against the penetration of spurious/substandard pharmaceutical products,” said a state drug controller, requesting not to be named. “The nature of the risks involved is similar to that encountered in the manufacturing environment, for instance, mix-ups, adulteration, contamination, cross-contamination, spurious. The involvement of unauthorized people in the distribution and sale of pharmaceutical products is a particular concern,” the official cited above said, adding that these guidelines can be used as a tool to curb the distribution of substandard and spurious products. The guidelines underlined the procedures to ensure a safe, transparent and secure distribution system which includes product traceability throughout the supply chain. It said that there shall be procedures in place to ensure document traceability of products received and distributed, to facilitate product recall, the guidelines said. All individuals involved in supply-chain of drugs must ensure that all pharmaceutical products have documentation that can be used to trace the products throughout distribution channels from the manufacturer to importer to the entity responsible for selling or supplying the product to the patient or his or her agent. Records including expiry dates and batch numbers shall be part of a secure distribution documentation enabling traceability. It shall be ensured that records of dispatch contain enough information to enable traceability of the pharmaceutical product. ‘Such records shall facilitate the recall of a batch of a product, if necessary, as well as the investigation of spurious or potentially spurious pharmaceutical products; the assigned batch number and expiry date of pharmaceutical products shall be recorded at the point of receipt to facilitate traceability,” it said. The guidelines also state that senior management of each entity should be responsible for ensuring that an effective quality system is established, resourced, implemented and maintained, and periodic meetings held to review the work. Source: Drugs Control