Latest news with #DCGI
The Hindu
5 days ago
- Health
- The Hindu
The paradox of market restriction for anti-TB drugs
Tuberculosis (TB) could be drug sensitive (DS TB), which can be treated by a few first-line oral drugs, or drug resistant (DR TB), wherein there is resistance to one or more drugs, making it difficult to treat, potentially leading to more complications and even death. Drugs for any form of TB are provided free of cost through the Indian government's National Tuberculosis Elimination Programme (NTEP). Newer anti-tubercular (anti-TB) drugs like Bedaquiline, Delamanid and Pretomanid are key drugs that have revolutionised the treatment of DR TB, since they are orally administered and require shorter treatment durations compared to the older regimen of daily injections, which were to be taken for many months. Another key drug is Rifapentine, which is mainly used to prevent TB in people who have come in contact with TB-infected individuals or in people with HIV disease. The Drugs Controller General of India (DCGI), following a letter from the Central TB Division of the Ministry of Health & Family Welfare, mooted an important proposition regarding the regulation of newer anti-TB drugs in the private market, in the 66th Drugs Consultative Committee (DCC) meeting held on June 17, 2025. The DCGI is planning to restrict access to the newer anti-TB drugs Bedaquiline, Delamanid, and Pretomanid and Rifapentine by making them conditionally accessible only through NTEP, in adherence to the Standards of TB Care in India. The reasons and implications of this move need to be closely examined. The mechanism of supplying drugs under NTEP NTEP has its own exclusive procurement and supply chain management system for anti-TB drugs, laboratory consumables and TB preventive drugs. India, like many countries in the world, procures most of its anti-TB drugs from the Global Drug Facility (GDF ) , a not-for-profit establishment funded by the Global Fund, along with procurement via domestic funding through the Central Medical Services Society . GDF does not aim to make a profit and therefore provides drugs and consumables at very low prices to countries through bulk procurement. The Central TB Division places an order to GDF at least one year prior by forecasting the need, based on the disease burden in the country. The drugs are then routed through Government Medical Store Depots to State Drug Stores of NTEP, from where they go to District Drug Stores and then down to DOTS centres at Tuberculosis Units and Peripheral Health Institutions. This entire process is managed real-time through a portal called Ni-Kshay Aushadh i , which is accessible only to NTEP personnel. The Central procurement of drugs is based on drug requests received from peripheral health institutions at the grassroots level. Timely online drug requests through the Ni-Kshay Aushadhi portal are imperative for uninterrupted procurement and supply of drugs in NTEP. However, studies have shown the sub-optimal use of the portal in the field owing to various reasons like lack of digital literacy and training of peripheral level staff, portal interface not being user-friendly and stock planning and forecasting not being perceived as a 'felt need' by staff. Why restrict access to newer anti-TB drugs A new drug that is developed can be patented by the company that developed it (originators) for a minimum of 20 years. No other company can undertake commercial production of the drug during this period. However, when a drug goes off-patent (expiry of patent period), it can be manufactured by any other pharmaceutical company and can be marketed for use. Patenting was done in the case of Bedaquiline (Johnson & Johnson), Delamanid (Otsuka), Pretomanid (TB Alliance) and Rifapentine (Sanofi) by their originators. These drugs are procured by the government and available only through NTEP to registered beneficiaries. Over the past 5 or 6 years, patents for all these drugs have expired, except for Pretomanid, and several generic pharmaceutical companies like Lupin, Macleods, Natco, etc. have taken up the production of these drugs, leading to lower costs and more availability in the market. Since they are off-patent, these companies could produce them for the open market as well. The easy availability and low prices of antibiotics in the open market drive private prescriptions, often leading to their injudicious use. This, in turn, promotes the emergence of drug-resistant bacterial strains, ultimately rendering these antibiotics ineffective. With the advent of drug-resistant and extensively drug-resistant strains of bacteria, TB treatment is already facing a crisis which warrants the discovery of newer drugs. Hence, the move of DCGI assumes importance in the journey to combat antimicrobial resistance. Making them conditionally accessible through NTEP would ensure rational use of these drugs. Possible implications of the restriction However, there are certain risks to this decision if implemented in the current context. In the event of a break in the supply chain of NTEP, these drugs would become unavailable for the persons with TB (PwTB) who are supposed to take them regularly, most often daily, without missing the doses. A terrible drug stock-out of anti-TB drugs during 2023-24 is an example of this threat. The stock-out affected almost every State in India and occurred both for DS-TB and DR-TB drugs. PwTB and their families had to run from pillar to post to obtain drugs needed daily for even the most common DS-TB regimen. Since the NTEP centres ran out of stock, a few PwTB who could afford it, sourced drugs from the open market. For persons affected by DR-TB, since drugs were available only through NTEP, they had to take incomplete regimens or miss their doses altogether. Lack of an alternative source to obtain drugs can be detrimental for PwTB if similar situations arise in future. Missed or incomplete doses can lead to delays in cure or no cure, increased risk of development of drug resistance and increased out of pocket expenditure for patients. This also leads to loss of trust in government systems built over several years, and in the larger picture, is a deterrent to our goal of TB elimination. Also Read: Gross mismanagement: On TB drug shortages and India's national TB programme What can be done? The proposition to make newer anti-TB drugs accessible only through NTEP is a welcome move, provided the government ensures a reliable and uninterrupted supply of drugs through the programme. Similar to how the Ni-Kshay dashboard on real-time disease burden in the country is visible to the public, the Ni-Kshay Aushadhi dashboard depicting available stock of drugs should also be made accessible. This would ensure accountability and help public health advocates to forecast and flag any potential drug stock-outs. A high level of vigilance from civil society is required to ensure that stock-outs at the regional level are predicted, prevented or mitigated. The existing TB Mukt Panchayat initiative could be leveraged for the involvement of local self-governments (gram panchayats) in doing the same. Accountability of the programme to provide drugs to all beneficiaries can be attained if people in power are also devoted to the cause. The idea to restrict the availability of newer anti-TB drugs therefore, must be implemented after careful planning and adequate groundwork, in order to prevent any interruption of access to eligible individuals. (Swathi Krishna Njarekkattuvalappil is a public health physician and researcher based in Pune, working in tuberculosis, health policy and systems research. swathikdk@ Parth Sharma is a community physician and a public health researcher based in Delhi.
News18
5 days ago
- Health
- News18
'No Suitable Successor': Govt Defends DCGI's Re-Employment, Says Move Backed By Public Interest
Last Updated: The government said there is no challenge to Raghuvanshi's eligibility and several other petitions, now dismissed as withdrawn, were raised to block the reappointment The Union government has strongly defended its decision to re-employ Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi after his superannuation, calling the legal challenge to the move 'malafide" and 'speculative". The government has asserted that the appointment was made in public interest with the express approval of the Appointments Committee of the Cabinet (ACC). The DCGI heads the Central Drugs Standard Control Organisation (CDSCO)—the country's apex health regulatory authority overseeing the regulation, manufacture, import, export, sale, and distribution of medicines, cosmetics, vaccines, and medical devices. As per an official notification from the Department of Personnel and Training (DoPT) under the Ministry of Personnel, Public Grievances and Pensions, Raghuvanshi has been re-appointed on a contractual basis for one year, effective from March 1, 2025—following his superannuation. The government clarified that this extension would remain in effect until a regular appointment is made or until further orders, whichever is earlier. The re-employment was made by temporarily keeping the recruitment rules in abeyance. However, the decision has been legally challenged for allegedly bypassing established recruitment norms for a position of such critical regulatory importance. In the official response submitted to a writ petition filed in the Madurai High Court, the Centre has questioned the locus standi and alleged that the petition was filed with 'ulterior motives and for extraneous reasons". 'The central government has claimed that the petition is not maintainable and told the court that the allegations of malafides or arbitrariness remain unsubstantiated, and the petitioner has not discharged the burden of proof," a senior official privy to the development told News18, requesting anonymity. Raghuvanshi A 'Distinguished Scientist' The re-employment of the DCGI—a post the government described as holding 'great importance for the Indian pharma market"—was made for a fixed period of one year or until the appointment of a regular incumbent, 'whichever is earlier". The Centre has clarified that the rules were kept in 'abeyance temporarily" and this was permissible under existing DoPT guidelines. The government has noted that there is no challenge to the eligibility of Raghuvanshi and mentioned that several other petitions, now dismissed as withdrawn, were also raised aimed at blocking the reappointment. 'The regular selection process is still ongoing. To maintain regulatory continuity and public health safeguards, the government made a short-term contractual re-employment in the interim," said the official, explaining the contents of the reply submitted to the court. Noting that the post of DCGI is filled via deputation, including short-term contract and not through promotion, the government has clarified that restricting the appointment to promotion would create vested interests in such a 'highly technical and sensitive regulatory post". Raghuvanshi, the Centre's reply stressed, is responsible for the quality, safety, and efficacy of drugs, cosmetics, and medical devices in the country, and also plays a key role in licensing imports, clinical trial approvals, and new drug introductions. Hence, it is the responsibility of the Union government to ensure that the person holding this post has the highest level of qualifications and experience. 'The reply calls Raghuvanshi a distinguished scientist having a credible record and achievements," the official said. In-house officers not suitable The government clarified that the post of DCGI is not a promotional position and is not filled from within the feeder cadre, but through deputation, including short-term contract (ISTC) as per the recruitment rules. It added that officials from within the organisation, provided they meet the eligibility criteria, are also free to apply. The reply explained that in the past, one joint drugs controller had been appointed as DCGI on deputation, while another had held the position on an ad-hoc basis. However, at present, it said, none of the four serving joint drug controllers are considered suitable for regular appointment. 'Two officers do not meet the prescribed eligibility criteria, one is facing prosecution by the CBI under various charges including corruption, and the fourth — who had been posted to Hyderabad due to his wife's medical condition — was on extended leave for over 18 months and is reportedly not attending office regularly." The reply also underscored that exceptional circumstances justified the decision and claimed the appointment was fully within the bounds of law. Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
Mint
09-07-2025
- Health
- Mint
From factory to pharmacy: Will new transit rules ensure safer drugs?
New Delhi: India is working on new rules to ensure that medicines purchased by customers are safe and haven't lost their efficacy during transit from manufacturing units to the pharmacies. Proposed new guidelines also call for clear traceability rules for everyone handling these medicines, starting from their origin to their user, to prevent spurious and substandard drugs entering the supply chain, said two government officials aware of the development. Currently, the rules are lax about storage during transit and are not mandatory, leading to concerns about their quality. A special committee, chaired by India's apex drugs regulator—Drugs Controller General of India (DCGI)—met recently and discussed the draft rules. These propose that each stage of packaging must have printed 2D barcodes along with legible text containing important details including the unique product code (GTIN), batch number, expiry date, manufacturing date, and a serial number. This will help track medicines through their transit journey. In addition, every entity handling the transportation must record details of the product, receivers and senders, and the time and place of transaction. This comes in the backdrop of the Central Drugs Standard Control Organization (CDSCO) developing a comprehensive national action plan to combat substandard and spurious medical products in the country as reported by Mint earlier. There have also been instances when medicines meant for hospitals (marked "not for retail sale") have been mixed with regular pharmacy stocks, amid complaints about expired or damaged products. 'The Drug Consultative Committee (DCC) in its meeting last month discussed an important issue of drug storage during transit. It was noted that current guidelines aren't mandatory, which means drug manufacturers aren't consistently ensuring proper storage conditions until the products reach wholesale and retail levels. To address this, a draft guideline has been prepared, aligning with updated WHO (World Health Organization) standards. However, the proposed guideline needs to be discussed with stakeholders including the drug manufacturers and distributors before any final decisions are made," said one of the government officials cited above requesting anonymity. The proposed rules call for Good Storage Distribution Practices (GSDP) that are essential to ensure the quality, safety, and efficacy of medicines throughout the supply chain from the manufacturer to the end-consumer. Medicines are sensitive products that can degrade due to improper storage, exposure to extreme temperatures, or mishandling during transit. GSDP also helps in stopping fake and substandard drugs from getting into the market, and allows for tracking. 'Right now, these crucial guidelines aren't a mandatory part of the Drugs Rule, 1945. Therefore, the plan is to put good storage and distribution practices in the Drugs Rule, thereby making them a legal requirement for everyone involved, including drug manufacturers, distributors, and retailers. This will ensure that medicines maintain their quality and effectiveness across the entire supply chain. A draft notification will be issued to make this provision legal, once things are finalised," said the second official cited above who also did not want to be named. The development assumes significance given that India's pharmaceutical market is valued at $50 billion and is ranked the third-largest by volume and 14th by value. India is the largest global supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic drugs across 60 therapeutic categories. Queries emailed to the spokespersons of the health ministry and DCGI remained unanswered till press time. Rajiv Singhal, General Secretary of All India Organization of Chemists and Druggists (AIOCD), which says it represents about 1.2 million chemists and distributors across India, said that everyone involved has an important role to play. 'Wholesalers and distributors also need to report any suspicious or fake drugs. They need to store medicines properly. Pharmacies and chemists should also store drugs as recommended, check their quality and expiry dates before selling them, keep good records of sales and purchase, and educate the patients on how to use and store medicines safely," Singhal said. Manufacturers say the Centre's initiative to introduce mandatory 2D barcoding and comprehensive traceability across the pharmaceutical supply chain is a much-needed step. 'It will go a long way in tackling issues like counterfeiting, pilferage, and improper storage during transit. More importantly, it will create a culture of accountability across every stakeholder, from manufacturers to distributors to retailers. While there may be some implementation challenges for smaller players, the long-term gains in patient safety, quality assurance, and global confidence in Indian pharma far outweigh the short-term hurdles," said Entod Pharmaceuticals chief executive officer Nikkhil K. Masurkar. 'We view drug delivery as a critical extension of our commitment to quality and patient safety. Ensuring that medicines are transported and handled under controlled, compliant conditions is as important as how they are manufactured. We've invested in robust cold-chain systems, GPS-enabled tracking, and tamper-evident packaging to maintain product integrity throughout the supply chain. Drug delivery is not just about logistics, it's a matter of public health," added Masurkar, whose company manufacturers medicines such as specializing in ophthalmology, ENT (ear, nose, and throat), and dermatology.
&w=3840&q=100)
Business Standard
07-07-2025
- Health
- Business Standard
Work on HC-ordered CDSCO panel on weight loss drug may begin mid-July
A Delhi HC directive to examine unregulated use of weight loss drugs may lead to a CDSCO expert panel by mid-July, possibly led by DCGI with pharma and govt representation New Delhi The Central Drugs Standard Control Organisation (CDSCO) may begin work on forming a court-ordered expert panel to examine the unregulated use of weight loss drugs by mid-July, according to sources. Officials in the know told Business Standard that the panel could be led by the Drug Controller General of India (DCGI) and may include the Director General of Health Services (DGHS) and officials from the Department of Pharmaceuticals as members. 'There are discussions that pharmaceutical associations would be asked to join as well to give an industry viewpoint,' an official aware of the matter said. The CDSCO did not respond to queries emailed by Business Standard till the time of going to print. The panel is also expected to review the possible unregulated use of anti-diabetic drugs for weight loss within the court's three-month deadline to respond to the petitioner. The directive followed a Public Interest Litigation (PIL) filed by fitness entrepreneur Jitendra Chouksey, raising concerns over the marketing approval granted for drugs such as semaglutide, tirzepatide and liraglutide for weight management despite limited safety data and a lack of India-specific clinical trials. The direction comes amid a wave of weight loss drug launches by multinational pharmaceutical companies in India. US-based Eli Lilly launched Mounjaro (tirzepatide) in March, while Danish drugmaker Novo Nordisk launched Wegovy (semaglutide) last month. These drugs, administered as once-a-week injections, belong to a class of therapies known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help regulate blood sugar and slow digestion, making users feel full for longer. According to standard guidelines for obesity management medications (OMMs), weight loss drugs are approved for patients with a Body Mass Index (BMI) over 27 and at least one obesity-related comorbidity, such as Type-2 diabetes, hypertension or high cholesterol. However, doctors report growing interest from individuals who do not meet the medical criteria. 'We are strictly discouraging its use for cosmetic purposes or in patients who do not meet the clinical threshold,' a Delhi-based endocrinologist said.
&w=3840&q=100)
First Post
07-07-2025
- Health
- First Post
Is your makeup safe? Why is India looking to ban mercury-based cosmetics?
The next time you apply that skin-lightening cream or your eye makeup, think again. It might contain the harmful chemical element mercury. The Government of India is now even mulling a ban on mercury-based cosmetics owing to the dangers they pose to the human body read more The Indian government is now considering a ban on mercury-based cosmetics, Most often mercury is used in eye makeup and in skin-lightening creams. Representational image/Pixabay The death of actor-model Shefali Jariwala has sparked a national debate on the safety of anti-ageing and skin-whitening products. As the discussion rages on, have you ever wondered what's in your makeup and if it could cause more harm than good? It seems the government of India has asked this question and is now considering a ban on mercury-based cosmetics, citing the dangers it poses to the human body. News reports state that the Centre is mulling a ban on mercury-based cosmetics after receiving a recommendation from a Drugs Controller General of India (DCGI) to ban such formulations — in accordance to the global Minamata Convention, which is designed to protect human health and the environment from the harmful effects of mercury and its compounds. STORY CONTINUES BELOW THIS AD What is the government's new move against makeup? The Centre is considering a ban on all mercury-based cosmetics containing more than one ppm (parts per million of mercury) based on the recommendations passed by the DCGI. 'Mercury use in the formulation of cosmetics has to be stringently discouraged/stopped,' the sub-committee recommended, according to minutes of a meeting reviewed by Mint. In India, mercury content is already limited under Rule 39 (5) of Cosmetics Rules, 2020. In eye make-up, the level of mercury should not exceed 70 parts per million (0.007 per cent), calculated as the metal, as a preservative. In other finished cosmetic products, 'unintentional mercury shall not exceed 1 ppm'. However, the DCGI wants stricter standards, which align with the Minamata Convention that calls for a complete ban on the use of mercury. Now, if the government does adhere to the DCGI's recommendations, it would be looking to identify cosmetics containing mercury and phase out their sale from the $20-billion Indian cosmetics market and from online platforms this year. For this purpose, the government may ask cosmetic companies to self-declare whether they use mercury. This will be followed by surprise lab tests and random sampling by regulators such as the Central Drugs Standard Control Organisation (CDSCO). As an official told the Mint, 'Keeping mercury stocks alive for even 'safe' proportions maintains its trade, creating multiple points for potential environmental contamination during stocking, manufacturing, procuring, and transportation. 'So, the logical step is to require manufacturers to self-declare their use of mercury, propose alternative formulations, and give them a strict deadline for phasing out mercury. These companies will also be required to give mandatory certification and random testing by the CDSCO by picking samples from the market.' STORY CONTINUES BELOW THIS AD The WHO has warned that from anti-ageing creams and eye makeup to skin-whitening lotions and nail polishes, mercury has found its way into a wide range of beauty products. Representational image/Pixabay How dangerous is mercury in cosmetics? Mercury has often been used in makeup products such as anti-ageing creams and eye makeup to skin-whitening lotions and nail polishes. Experts note that mercury has been added to cosmetics as it is has the ability to whiten skin. The World Health Organisation (Who) has earlier issued a warning against the use of mercury noting that the toxic chemical is used in skin lightening soaps, creams and cosmetics like eye makeup, cleansing products and mascara. However, makeup formulations containing mercury pose dangers to the human body. Exposure to mercury can cause irritation. According to the US' Food and Drug Administration (FDA), users could develop redness, itching and rashes. It could also lead to hives. Experts also note that prolonged use of mercury-based cosmetics could results in dermatitis, which is inflammation or the skin, or in extreme cases even cause permanent skin discolouration. Mercury-based cosmetics could also penetrate the skin barrier and enter the bloodstream, leading to systemic toxicity; it could cause damage to the central nervous system, which could be seen in symptoms such as tremors, memory problems, mood swings, and cognitive dysfunction. The use of mercury-based makeup could also lead to kidney damage and can weaken the immune system, making the body more vulnerable to infections and diseases. In fact, in 2022, there was a case of a woman in Minnesota in the United States, who lost part of her vision, as a result of mercury poisoning, most likely from using beauty creams containing high levels of the toxic chemical. STORY CONTINUES BELOW THIS AD Experts also note that mercury in cosmetics is eventually discharged into wastewater. It enters the environment, where it becomes methylated, and enters the food chain as highly toxic methylmercury in fish. Pregnant women who consume fish containing methylmercury can transfer it to their offspring, resulting in neurological conditions. 'Mercury poisoning from skin-whitening creams can be very serious, as it causes nervous system damage that can be permanent,' said Dr Eric Lavonas, a toxicologist with Rocky Mountain Poison and Drug Safety in Denver, Colorado, and a spokesperson for the American College of Emergency Physicians, to F_ox News._ The one way to protect yourself from mercury poisoning is read the labels of the cosmetics you buy. If it contains mercury, refrain from buying it. Representational image/AFP How prevalent is the use of mercury in makeup? But despite the dangers of mercury, it is still used in cosmetics. In 2022, the Zero Mercury Working Group tested 271 products bought in 15 countries over a 13-month period and found nearly half to be contaminated with the dangerous heavy metal at levels above 1 part per million (ppm). Michael Bender, international coordinator with the Mercury Policy Project, told The Guardian, 'We're not finding 1 ppm – we're finding products that are hundreds or thousands or tens of thousands of times above [1ppm. These levels are astronomical.' And this January, cosmetics worth over Rs 7 lakh were seized for failing to adhere norms in Kerala. Tests conducted on lipstick and face cream samples revealed mercury levels exceeding permissible limits, with some samples showing mercury levels 12,000 times higher than allowed. STORY CONTINUES BELOW THIS AD How can customers protect themselves? If you want to steer clear of mercury-based products, the first thing to do is read — read the product labels carefully. Also, steer clear of skin-lightening creams as they tend to contain mercury. Experts also note that customers should avoid buying 'suspiciously' cheap products and shop from reputable stores. As Michelle Wong, a Sydney-based science educator and beauty influencer, told ABC News, 'If there's things that don't seem right, things like misspelt words on the product, then it probably isn't very legitimate.' With inputs from agencies
