May 2024

May 23,2024 Bengaluru: Patients visiting government hospitals in Karnataka recently were shocked when they noticed that some drugs had labels of Animal Husbandry Veterinary Sciences (AHVS) but the department concerned has said it was only a logo related issue and that the medicines were indeed meant for human use. The Karnataka State Medical Supplies Corporation Limited (KSMSCL) said there was an error in the ‘logogram’ design, but the product was of standard quality and ‘human use only’. As the typo led to panic among patients, KSMSCL Managing Director Chidananda Sadashiva Vatare said in a statement that the product permission copies were submitted and confirmed they were permitted to manufacture as per required medical standards and for human use only. According to sources in KSMSCL, there were seven drugs which had the AHVS label. This included eye and nasal drops. These drugs were supplied by a private firm with a total value of Rs 62.9 lakh and it reached the government warehouse on January 5, this year. The drugs were Methyl Prednisolone injection, Carboxymethylcellulose Eye Drops, Oxymetazoline Pediatric (Nasal) Drops, Flurbiprofen Eye Drops IP, Sodium Chloride (Nasal) Drops, Timolol Maleate Drops and Oxymetazoline Hydrochloride (Nasal) Solution IP. “The analytical test reports from NABL/government approved laboratories and in-house test reports of the products opined as the products referred above are of standard quality. The test reports from the private empanelled laboratories of KSMSCL have reported these products are of standard quality,” Vatare said. The products were supplied to all the warehouses in the state by the supplier by January 5, he said, adding the supplier requested KSMSCL on January 18 to accept the supplied products by masking the typo. “It is to be noted that no changes were done in the label of the product information provided. Also, the logogram design was correct in one part of the product and only in another part was there a printing error in the logogram design which was masked, where instead of Health department it was typed as AHVS department.” “The supplier was also imposed a fine of one per cent on the purchase order value and all warehouses were instructed to distribute the products only after masking the error. The supplier was also warned not to repeat the mistake,” he said. Source: Healthworld

May 24,2024 The Central Drugs Standard Control Organisation (CDSCO) has declared that 50 drug samples tested in both Central and State drug laboratories have failed the quality standard test during the month of April, 2024. The Central drug regulator said that almost 21 states have not submitted any data in respect of the Not of Standard Quality (NSQ) alert for the month, while another two States have not submitted the data in prescribed format. Out of the 50 NSQ samples published for the month of April, 33 were tested in CDSCO laboratory while the rest of the samples were tested in state/Union Territory laboratories including Jammu & Kashmir, Goa, Kerala, and Madhya Pradesh. Drug Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, and West Bengal, and Union Territories of Andaman Nicobar, Dadar and Nagar Haveli, Daman and Diu, and Lakshadweep have not submitted any data in respect of the NSQ alert for the month, despite a circular from the Drugs Controller General (India) (DCGI) directing submission of the data issued on February 9, 2024, said CDSCO. NSQ data was not received as per the format and in a prescribed file from the State Drugs Licensing Authorities of Karnataka and Uttar Pradesh for the month, said the Central regulator. State Drugs Licensing Authorities of Mizoram, Tripura and Puducherry have reported the NSQ data as nil for the month, it added. Unlike its practice in the past years, the NSQ alert for the month does not reveal the total number of samples collected and tested during the month. According to the alert, the samples failed the quality test include a sample of Norditropin Nordiflex 15mg/1.5 ml (human growth hormone injection) labelled as manufactured by Novo Nordisk, ofloxacin and ornidazole tablets from public sector undertaking Karnataka Antibiotics and Pharmaceuticals Ltd, Rez-Q 300 (quinine sulphate tablets 300 mg), and Thyrox-75 (thyroxine sodium tablets) labelled as manufactured by Shreya Life Sciences. The samples failed in the test conducted by State Drug Testing Laboratories include multiple samples supplied by Kerala Medical Services Corporation, Warfarin sodium tablet 5 mg labelled as manufactured by Centurion Remedies, Sallaki tablets labelled as manufactured by Gufic Biosciences, paracetamol paediatric oral suspension 125 mg/ml from Quest Laboratories, and paracetamol paediatric oral suspension 250 mg/ml from Zenith Drugs. It may be noted that the 63rd Drugs Consultative Committee (DCC) meeting held at the end of January sought the state drug regulators to submit data related to NSQs and spurious drugs on a monthly basis. The committee also mooted preparing a list of manufacturers who repeatedly produce Not of Standard Quality (NSQ) drugs and black list them. The Committee also noted that only a few states are sharing the NSQ data with the Central authority on a monthly basis and called for all the States to share the data periodically and in a timed manner for publication on the website. Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) (DCGI) during the meeting highlighted the concerns with respect to multiple NSQ drugs manufactured by the same manufacturer, and the need to watch such repeated offenders in future. “It was discussed about black listing of such manufacturers and preparing a list of such offenders so that the Government procurement agencies become careful before procurement of drugs from such manufacturers,” said the drug regulator. The Committee also looked at the status of the recommendation made with regard to the sharing of information on NSQs in the previous meeting. It observed that only a few states are sending the NSQ data on a monthly basis. The Central drug regulator sensitised all the States to look into the matter regarding any difficulties and to send the NSQ data periodically and in a timely manner, so that the information can be compiled and published on the website for the attention of all the stakeholders. The DCGI also requested all SLAs to strengthen or upgrade their State Drugs Testing Laboratories with the funds released by the Central Government as the Central Drugs Laboratories are overburdened with the cough syrup samples and others sent by the Central Drugs Standard Control Organisation (CDSCO) drugs inspectors. He also informed the SLAs that after a certain period of time, the CDLs will not accept samples from the states. The State Drugs Controllers urgently need to onboard the SLAs on the Online National Drugs Licensing System (ONDLS) for receiving applications and issuance of blood centre licenses online, added the Committee. Source: Pharmabiz

May 28,2024 New Delhi: Estimates show that 56.4 per cent of total disease burden in India is due to unhealthy diets, the ICMR said on Wednesday as it released 17 dietary guidelines to meet the requirements of essential nutrients and prevent non-communicable diseases (NCDs) such as obesity and diabetes. The National Institute of Nutrition (NIN) under the apex health research body said that healthy diets and physical activity can reduce a substantial proportion of coronary heart disease (CHD) and hypertension (HTN) and prevent up to 80 per cent of type 2 diabetes. “A significant proportion of premature deaths can be averted by following a,” it said, adding that the upsurge in the consumption of highly processed foods laden with sugars and fats, coupled with reduced physical activity and limited access to diverse foods, exacerbate micronutrient deficiencies and overweight issues. The NIN recommended restricting salt intake, using oils and fat in moderation, doing proper exercise, minimising sugar and ultra-processed foods. It also suggested adopting a healthy lifestyle to prevent obesity and reading information on food labels to make informed and healthy food choices. The Dietary Guidelines for Indians (DGIs) has been drafted by a multi-disciplinary committee of experts led by Dr Hemalatha R, Director, ICMR-NIN and has undergone several scientific review. Seventeen guidelines have been listed in the DGI. “Through the DGIs, we emphasise that the most logical, sustainable, and long-term solution to all forms of malnutrition is ensuring the availability, accessibility and affordability of nutrient-rich foods while promoting consumption of diverse foods. The guidelines contain in them scientific evidence-based information that would facilitate the attainment of goals stated in the National Nutrition Policy,” Hemlatha said. The dietary habits of Indians have undergone significant changes over the past few decades, leading to an increase in the prevalence of non-communicable diseases while some of the problems of undernutrition continue to persist, said Dr Rajiv Bahl, Director General, ICMR. “I am pleased that these guidelines have been made very relevant to the changing food scenario in India with addition of practicable messages and suggestions on handling food safety choosing minimally processed foods, importance of food labels and physical activity. I am sure these will complement the government’s efforts to promote holistic nutrition and health of our people,” Bahl said. Referring to the non-communicable diseases, the NIN said that 34 per cent of children between 5-9 years of age suffer from high triglycerides. A balanced diet should provide not more than 45 per cent calories from cereals, and millets and up to 15 per cent of calories from pulses, beans and meat. Rest of the calories should come from nuts, vegetables, fruits and milk, the guidelines said. Due to the limited availability and high cost of pulses and meat, a significant proportion of the Indian population relies heavily on cereals, resulting in poor intake of essential macronutrients (essential amino acids and essential fatty acids) and micronutrients, the NIN said. Low intake of essential nutrients can disrupt metabolism and increase the risk of insulin resistance and associated disorders from a young age, it said. Source: Healthworld

New Delhi: The Delhi High Court has dismissed a Public Interest Litigation (PIL) seeking direction from the Centre to mandate all medical professionals practising in the country to specify to a patient (in the form of an additional slip in the regional language) along with the prescription all kinds of possible risks and side effects associated with a drug or a pharmaceutical product being prescribed. The petitioner stated that upon being made aware of the side effects of the drug being prescribed by the doctor, the patient will be able to make an informed choice about whether to consume it or not. The petitioner, Jacob Vadakkanchery, through Advocates Prashant Bhushan and Anurag Tiwary, stated that prescription medications come with side effects that have the potential to do much harm. The patient has a right to make an informed choice and therefore, it should be mandatory for the doctor prescribing the drug to explain the side effects attached to consuming such a drug to the patient. The plea stated that in the existing regime, the obligation to communicate the potential risks and side effects exists on the manufacturer under Clause 6.2 of Schedule D(II) of the Drugs and Cosmetics Act, 1945 (‘Act of 1945’) and on the pharmacists under Regulation 9.11 of Chapter 4 of the Pharmacy Practice Regulations, 2015 (‘Regulations of 2015’). It also stated that, however, these stipulations in the law are not sufficient. It is the medical practitioner prescribing the drug who should be made responsible for handing out information about the potential risk to the patient in the regional language. Advocate Prashant Bhushan for the petitioner stated that prescribing a drug without specifying the possible side effects does not amount to obtaining valid consent of the patient. He stated that the emphasis in law on informing the patient must shift from the manufacturer and pharmacist to the medical practitioner. The medical practitioner should be the individual handing out the insert provided by manufacturers to the patient while prescribing the drug, as it would highlight the significance of the declarations made in the insert to the patient. He stated that patients do not tend to take serious note of the insert when it is provided by the manufacturer and/or the pharmacist. The bench of Justice Manmohan and Justice Manmeet Pritam Singh Arora passed an order on May 15, and since the legislature, in its wisdom, has elected to impose this duty on the manufacturer and the pharmacist, we do not find any ground for issuing a direction as prayed for in this PIL as it would amount to judicial legislation. Court further said that the Petitioner does not dispute with respect to the sufficiency of the information supplied by the manufacturer through the insert provided with the drug at the time of sale by the registered pharmacist. The Petitioner however, contends that if the same insert is provided by the doctor along with the prescription, it can be presumed that the patient/carer would be able to make an informed choice with valid consent. Appearing for Centre, counsel stated that the petition acknowledges that there exists sufficient legislation to ensure that the patient is aware of the potential risks and possible side effects of the drugs. He stated that the existing provisions in the Act of 1945 and the Regulations of 2015 ensure that the risk is duly communicated to the patient. He stated that the direction sought by the writ Petitioner is unworkable considering how overworked medical practitioners are and would hinder rather than facilitate medical advice to the patients. Source: Healthworld

May 25,2024 New Delhi: Children and adults diagnosed with high blood pressure have double the risk of major cardiovascular problems. It slowly damages almost all the vital organs including the heart, kidneys, eyes, and the brain. Its manifestations are usually seen in adults when they present with end-organ damage. At a growing age, children are getting hypertension which is between 15-20 per cent. “It’s alarming, warned an expert from All India Institute of Medical Sciences (AIIMS) Delhi on Friday. Speaking to ANI, Dr Sumit Malhotra, Professor, Centre for Community Medicine at AIIMS said, “Surveys, which are being done in different parts of the country, who have looked into the hypertension levels, we have actually found out that 15 to 20 per cent of the children and adolescents has high blood pressure and the rising figures are being consistently seen.” In children, hypertension is not as common as in adults; however, a globally increasing number of children are being diagnosed with hypertension. “Adolescents are not having a very good lifestyle in terms of physical activity, consumption of fruits and vegetables, also tobacco consumption. So all of this actually is indicative of a rise in hypertension,” he said further. Nowadays, with the increasing prevalence of obesity, sedentary lifestyle, and drug abuse in teenagers, the prevalence of primary hypertension in children is also increasing. Approximately 22 crore adults are estimated to have high blood pressure (BP) in India. There are gaps in its diagnosis, treatment, and control status, owing to a lack of awareness. Every Year, 17 May is observed as World Hypertension Day, and the whole month is dedicated to raising awareness about hypertension. The Union Health Ministry launched an ambitious 75/25 initiative of screening and putting 75 million people with hypertension and diabetes on Standard Care by 2025. To raise awareness among the general public, about hypertension, the public lecture and panel discussion, involving experts from diverse domains, was organised today on May 24. The event covered topics – measurement of BP, home monitoring, prevention, treatment and control, stress management, tobacco cessation, and complications. Several events were organised to raise awareness about screening for high BP including involvement and engagement of educational institutions like schools to tackle the rising burden of BP among young people. Source: Healthworld

May 26,2024 New Delhi: Twenty per cent of cancer patients who called an NGO-run helpline to seek a second opinion were below 40 years of age, indicating a rise of cancer incidences amongst younger people, data from the organisation stated. There were 1,368 callers between March 1 and May 15, according to the Cancer Mukt Bharat Foundation, launched by a group of oncologists. The study showed that 60 per cent of the cancer patients below the age of 40 years were men. It also found that the most prevalent cases were head and neck cancer (26 per cent), closely followed by Gastrointestinal cancers (16 per cent), breast cancer (15 per cent) and then blood cancers (9 per cent). The most number of calls were from Hyderabad, followed by Meerut, Mumbai and New Delhi, a statement by the NGO said. The helpline number (93-555-20202) was launched for the patients to seek second opinion free of cost. It is operational from 10 am to 5 pm from Monday to Saturday. Cancer patients can call the helpline number to speak to leading oncologists directly or even do a video call to discuss their cancer treatment. Dr Ashish Gupta, Principal Investigator and senior oncologist who is heading the Cancer Mukt Bharat Campaign said that since the launch of the helpline number, it has proven to be a support system for cancer patients across India and almost hundreds of calls are received every day. “This study helps us make a more targeted cancer approach towards treatment and make India ‘Cancer Mukt’. We found head and neck cancer was most prevalent which is nearly entirely preventable by lifestyle modification, vaccinations and screening strategies. Breast and colon cancers have very effective screening strategies for finding cancer in the early stages. Unfortunately as is representative of the population at large in India we found nearly 2/3rds of cancers were detected late likely due to low adoption of proper screening,” Dr Gupta said. The study also found that 27 per cent of cases diagnosed in India are in stages 1 and 2 of cancer whereas 63 per cent are in stage 3 or 4 cancer. The most common question of the cancer patients was for a second opinion and to confirm whether their cancer treatment was correct and up to date. Some also check the availability of the latest treatment or medicine to treat their respective cancer as in cancer treatment as new medicines are approved almost every week, he said. The second most common question we found was patients asking what stage their cancer is in indicating the importance of education to cancer patients and thirdly patients commonly asked regarding their family members, what they can do to prevent cancer highlighting the importance of cancer screening and awareness, he said. Cancer Mukt Bharat campaign aims to reduce the incidence and impact of cancer on individuals and communities through education and early detection, Dr Gupta said. Further, the study showed that 67 per cent of the cancer patients who reached out to the organization were the ones who were taking cancer treatment from private hospitals. While 33 per cent were those were taking treatments from government hospitals, he said. Dr Ashish Gupta further said, “In our country escalating rates of obesity, change in dietary habits, specifically the increase in consumption of ultra-processed food, and sedentary lifestyles also are associated with higher cancer rates. We must adopt a healthy lifestyle and avoid the use of tobacco and alcohol to prevent the risk of cancer in the younger generation”. The helpline number offers a free opinion from leading oncologists, providing crucial guidance to patients navigating the complexities of cancer diagnosis and treatment, he said. Source: Healthworld

May 27,2024 Mumbai: Dr Nancy Y Lee, MD, FASTRO, Radiation Oncologist and Early Drug Development Specialist, Memorial Sloan Kettering (MSK) Cancer Centre, interacted with ETHealthworld’s Prabhat Prakash on the rising burden of head and neck cancer cases in India, the role of HPV vaccination in HNC prevention and how low-dose radiation is demonstrating encouraging outcomes with a lower dose. Edited Excerpts: The uptick in HPV-related cancers, particularly impacting men’s head and neck areas, is quite a concern, alongside its better-known link to cervical cancer in women. Recent data from the Centers for Disease Control and Prevention (CDC) show around 25,000 cases of HPV-associated cancers in women and 19,000 in men between 2013 and 2017. Notably, more than four out of every ten cases of HPV-related cancer occur in men. Looking ahead, the projections are equally alarming. According to GLOBOCAN 2020, India is expected to see a staggering 57.5 per cent increase in new cancer cases by 2040, totalling 2.1 million cases. Factors contributing to this surge include a lack of awareness and screening, leading to delayed diagnosis and treatment. Multiple sexual partners and oral sex contribute to the rise of this cancer. Additionally, tobacco and alcohol consumption, prevalent among Indian men, interact with HPV infection, further increasing cancer risk. Furthermore, limited HPV vaccination coverage, especially among boys and young men, perpetuates HPV transmission. In India, one in 33 males and one in 107 females are at risk of developing HNC. Every step of cancer care has hurdles, right from diagnosis to follow-up. There is an increased diagnostic delay in these patients among the Indian population, either due to limited access to healthcare, a lack of understanding of the gravity of the situation, or financial constraints. According to the Indian Council of Medical Research (ICMR), over 60 per cent of HNC cases are diagnosed at an advanced stage, primarily due to the absence of widespread screening programmes and low awareness levels. Tobacco and alcohol consumption, prevalent cultural practices, are significant risk factors; the World Health Organisation (WHO) estimates that nearly one-third of all cancer-related deaths in India are attributed to tobacco use. Furthermore, a study published in the Indian Journal of Cancer highlighted the disparities in healthcare infrastructure, with rural areas facing a shortage of trained medical professionals and diagnostic facilities. IFHNOS has revolutionised head and neck cancer care on a global scale, uniting experts from 70 countries to share cutting-edge research, techniques, and best practices. One of the key ways in which IFHNOS has made an impact is through its international conferences, workshops, and educational programmes. These events provide a platform for experts from diverse backgrounds to share their insights, discuss challenges, and explore solutions in the diagnosis, treatment, and rehabilitation of head and neck cancer patients. In a recent collaboration with MSK and its Chennai centre, IFHNOS introduced a HNC summit. Additionally, MSK offers a Head and Neck Oncology Fellowship accredited by IFHNOS, showcasing its dedication to excellence in head and neck cancer care. We’re observing a notable shift in HNC care, moving away from traditional invasive procedures toward more precise and patient-friendly approaches. Techniques like microsurgery and minimally invasive procedures such as transoral laser and robotic surgery are preserving vital functions and enhancing outcomes. Advanced radiation therapies like proton beam and intensity-modulated radiation therapy deliver targeted treatment, minimising collateral damage. Immunotherapy is also revolutionising cancer care by leveraging the body’s immune system to combat tumours, while genomic testing allows for personalised treatment plans, optimising efficacy. Furthermore, participation in clinical trials provides access to cutting-edge therapies, offering hope for patients. Looking forward, these advancements will continue to redefine the head and neck cancer care landscape, emphasising personalised treatment and improved quality of life for patients. Source: Healthwolrd

May 25,2024 Abu Dhabi: The Board of Directors of the Emirates Drug Establishment (EDE) held its fourth meeting since its establishment at the end of last year, to review and develop the main initiatives to be taken for the regulation and management of the UAE’s healthcare and pharmaceutical sectors – all of which are designed to reinforce the UAE’s reputation as a global and regional hub for the medical industry. The meeting was chaired by Dr Thbin Ahmed Al Zeyoudi, Minister of State for Foreign Trade and Chairman of the Board of Directors of the EDE, and was attended by Dr Maha Tayseer, Deputy Chairperson of the Board, Dr Fatima Mohammed Hilal Al Kaabi, Director General of the EDE, as well as board members Dr Issa Abdul Fattah Kazim, Badr Saleem Al Ulama, Dr Amer Ahmed Sharif, Dr Farhan Malak, and Professor Chris Evans. Ahmed Al Rumaithi has recently joined the Board as a representative of the UAE’s youth. During the meeting, the Board of Directors discussed the development of plans for the establishment of various specialised committees to enhance the EDE’s operational efficiency. The attendees also reviewed the latest developments regarding plans to integrate the activities of all relevant government agencies and services, including the transfer of supervision of more than 160 services from the Ministry of Health and Community Prevention and the Ministry of Climate Change and Environment to the EDE. Dr Thani said that the EDE is continuing its work to establish a fully integrated organisational structure that will regulate and manage all healthcare and pharmaceutical activities in the UAE. Its goal is to enhance standards, drive innovation, and stimulate cooperation in advanced research that will elevate the UAE’s healthcare industry to be in line with global best practices. Al Zeyoudi said, “We are focused on developing the institutional, organisational and administrative structure of the EDE, which will support the integration of relevant government agencies and services into our mandate. This is an important part of our efforts to enhance the UAE’s healthcare and pharmaceutical sector in line with global standards. We are determined to elevate the production capability and capacity of the local pharmaceutical sector in order to better cater for our needs, foster national excellence in this vital sector and attract both investment and talent from around the world.” As Director General of the EDE, Dr Fatima Al Kaabi stated that they are working on plans to implement previous recommendations of the Board of Directors, including the establishment of the EDE’s organisational structure and the appointment of a highly skilled and experienced team to oversee the continued improvement of healthcare standards in the country. Al Kaabi stated, “The EDE is working to establish its organisational structure that will help us achieve our strategic goals, elevating the standards and accelerating the expansion of our country’s healthcare and pharmaceutical sectors, increasing their contribution to the well-being of the UAE’s citizens as well as contributing to sustainable economic growth.” The UAE Cabinet approved the formation of the Board of Directors for the Emirates Drug Establishment in December 2023. Source: Healthworld

May 27,2024 Chicago: The United States and Europe are taking steps to acquire or manufacture H5N1 bird flu vaccines that could be used to protect at-risk poultry and dairy workers, veterinarians and lab technicians, government officials said, moves influensa experts say could curb the threat of a pandemic. U.S officials last week said they were moving bulk vaccine from CSL Seqirus that closely matches the current virus into finished shots that could provide 4.8 million doses of vaccine. European health officials told Reuters they were in talks to acquire CSL’s prepandemic vaccine. Canadian health officials said they have met with GSK, maker of Canada’s seasonal flu shots, to discuss acquiring and manufacturing a prepandemic bird flu vaccine once its seasonal flu production capacity is freed up. Other countries, including the UK, are discussing how to proceed on prepandemic vaccines, scientists said. The actions follow the explosive spread of a new strain of bird flu that emerged in late 2020 and has caused unprecedented numbers of deaths among wild birds and domestic poultry and has begun infecting many mammal species. In March, US officials reported the first outbreak of the virus in dairy cattle, which has infected dozens of herds in nine states and two dairy workers. The US Food and Drug Administration has estimated that 20 per cent of the US milk supply shows signs of the virus, indicating a wider spread is likely. Human exposures to the virus in poultry and dairy operations could increase the risk that the virus will mutate and gain the ability to spread easily in people. “All of our efforts need to be focused on preventing those events from happening,” said Matthew Miller, co-director of the Canadian Pandemic Preparedness Hub at McMaster University. “Once we have widespread infections of humans, we’re in big trouble.” Dr Angela Rasmussen, a virologist at the University of Saskatchewan, said she has been in discussions with US and Canadian officials about using vaccines to protect workers following the virus’ spread into new mammal species. Dawn O’Connell of the US Administration for Strategic Preparedness and Response said the government is “looking closely” at the possibility of vaccinating farm workers and others in close contact with the virus. The US has contracts with CSL and GSK to test prepandemic vaccines that more closely match the circulating virus than older H5N1 vaccines in the stockpile. The US is moving forward with the CSL vaccine, a Department of Health and Human Services official confirmed. Discussions about prepandemic vaccine use are going on at government levels and among scientists in a number of places, including in the UK, said Wendy Barclay, chair in influensa virology at University College London, who also researches avian flu for the UK Health Security Agency. Source: Healthworld

May 28,2024 New Delhi: A five-member expert committee will examine if manufacturing of nutraceuticals should be allowed within drug manufacturing facilities. India’s drug regulator had said earlier that action will be taken against those flouting norms by manufacturing supplements and drugs in the same facility. However, following objections raised by various pharma lobbies, the drug regulator has formed a committee that will give its recommendations within three weeks on the issue. The committee comprises senior officials from the regulatory authority, experts from the National Institute of Pharmaceutical Education and Research (NIPER) and an industry expert. “It has been decided to constitute a committee to examine the request of the industry associations to consider permitting manufacturing nutraceuticals in drug manufacturing facility,” said the notice dated May 27. “The committee shall submit the report within the time period of three weeks,” the notice said. ET had earlier reported that the government may “reconsider” its decision to act against pharmaceutical companies manufacturing nutraceuticals, health supplements and drugs in the same facility following objections raised by industry bodies. Federation of Pharma Entrepreneurs (Fope), a pharma lobby that works with micro, small and medium enterprises (MSMEs), had said any clampdown in this regard will affect not only exports but also the domestic market. Under the revised Schedule M of Drugs and Cosmetics Act 1940, a manufacturing facility approved for drugs cannot be used for manufacturing other products. Executives of Fope had also met the health secretary and the Drug Controller General of India (DCGI) seeking an exception to select units as was given earlier. An exception was earlier provided to the units established prior to December 2001, he said. “Subsequently, this concession was extended to all manufacturing establishments by the DCGI under his letter dated March 1, 2007, based on the decision of the Drugs Consultative Committee in its 37th meeting,” an industry expert said. Source: Pharma