Latest news with #FoodandDrugsAdministration
India Today
18 hours ago
- Health
- India Today
Sunscreens and hormone health: What you should know before you apply
As the summer continues to blaze and skin protection becomes a daily essential, growing questions around sunscreen ingredients and their potential long-term health impacts are starting to studies and international safety reviews have highlighted concerns about certain chemical ingredients commonly used in sunscreens, particularly their ability to be absorbed into the bloodstream and act as hormone disruptors.A hormone disruptor is a chemical that has the ability to cross cell membranes and interfere with the body's natural hormone But dermatologists stress that this does not mean sunscreens are unsafe or should be avoided it's a reminder to be more informed about what we apply on our skin every day."The concern for safety and effectiveness of sunscreen ingredients has been heightened after recent evidence of their measurable systemic absorption following topical application," Dr. Sarita Sanke, dermatologist at Yashoda Super Speciality Hospitals, Kaushambi, told the ingredients drawing attention are oxybenzone and octinoxate, two UV filters widely used for their ability to absorb harmful UVB and UVA rays of the both have also been found in blood, urine, breast milk, and even amniotic fluid, raising questions about their possible impact on hormonal balance and foetal these ingredients are not banned and continue to be approved for use in many countries, including India, doctors say more research is US FDA (Food and Drugs Administration) has highlighted the importance of further evaluating all sunscreen ingredients with systemic absorption levels over 0.5 ng/mL, Dr. Sanke SUNSCREEN DISRUPT HOMONES?Some studies have pointed to possible associations with thyroid changes, pubertal development, kidney function, and immune health, though these findings remain ingredients under scrutiny include homosalate, avobenzone, octisalate, and octocrylene, all commonly found in many commercial sunscreen formulations and approved by the US the research is far from definitive.'Octinoxate and oxybenzone are also present in plastic packaging, water, air, and cosmetics. While detected in body fluids, their systemic exposure hasn't been proven harmful in humans,' said Bengaluru-based dermatologist Dr. Divya added that sunscreen safety is still under active investigation globally, but no regulatory agency has so far called for discontinuing their SHOULD CONSUMERS DO?Both Dr. Sanke and Dr. Sharma suggest that mineral sunscreens, which contain zinc oxide or titanium dioxide, could be a safer alternative for those ingredients physically block UV rays rather than absorbing them, and while they too can penetrate the skin in small amounts, the current data do not indicate fact, many sunscreen formulations available in India have already phased out older ingredients like PABA and triethanolamine, which were previously linked to safety some studies have raised concerns about sunscreen chemicals affecting fish microbiota and aquatic systems, no evidence yet links these effects to human advise that sunscreens are a critical defence against skin cancer and premature ageing, especially in a country like India where UV indices frequently sunscreen entirely out of fear would be misguided, doctors the advice is to choose wisely, look at ingredient labels, and opt for mineral-based products where possible, particularly for children, pregnant women, or those with sensitive skin.
RTÉ News
6 days ago
- Health
- RTÉ News
Bitter pill: EU exploits Trump anti-science climate to forge deal on medicines
The EU's sweeping new rules on the regulation of medicines has been one of the most bitterly contested pieces of legislation in recent times, with fierce lobbying by the pharma sector - particularly in Ireland - and member states divided on which to prioritise: cheaper medicines for patients, or a regulatory environment that supports indigenous European manufacturers in the face of US dominance. After two years of deadlock, 26 member states have agreed on a compromise proposal, with only Malta - which has its own small-market medicines challenge - abstaining. Ironically, it was the Trump administration's hostility to science and medicine regulators that convinced EU member states that the moment to finally agree on a new set of rules was at hand. "In the US you have a chaotic situation," says one source familiar with negotiations, "between [Health Secretary] Robert Kennedy Jr, who doesn't believe in science or vaccines, and the Trump administration, which has sacked three and a half thousand people from the Food and Drugs Administration. "There was a sense in Europe that we should try to get this proposal settled so that we have a stable system in Europe when there's instability elsewhere." The legislation will now go to the European Parliament, where negotiations between MEPs, the member states and the European Commission, begin on 17 June. There are hopes that the entire package could be adopted by the end of the year. The European Commission first proposed overhauling the EU's medicines regime in April 2023, as Europe was emerging from the Covid pandemic. The EU was reeling from the strain the emergency put on health systems and on the availability of certain kinds of medicines, with a deepening awareness that Europe was overly dependent on China and India for drugs such as antibiotics. At the same time, digitalisation and the availability of clinical data were opening up new possibilities in how medicines are developed and used. Despite that, innovative therapies were not reaching patients across Europe at the same speed while in some member states patients did not have access to medicines they needed due to shortages. The instinct to reduce health spending further has been given fresh impetus by the expected surge in EU defence expenditure following Russia's invasion of Ukraine. Overall, the pharma package sought to boost the competitiveness of the sector, reduce the administrative burden - and the over-reliance on India and China - and to tackle the environmental impact of drug manufacture and use. The central, most divisive issue was around the protection that big European pharma countries would have in holding on to clinical data before generic manufacturers - who could produce cheaper drugs - could access it. It became a straightforward contest between the competing interests of big pharma, which argued that companies needed the protection in order to invest more in life-saving domestic European research and innovation, and those countries which were more interested in lowering the cost of medicines and making those medicines more accessible to patients. The legislation was always going to face a stormy passage. "The difficulty was that the countries that didn't have pharmaceutical industries were very much opposing the regulatory data protection (RDP) element because all they were interested in was making medicines available to citizens," says Fianna Fáil MEP Billy Kelleher, a substitute member of the European Parliament health committee. "Eastern European countries like Poland, Romania, Bulgaria and others would have been very, very reluctant to support the strong protection of regulatory data, while it was the old West, countries like Ireland, Belgium, Italy, Germany and the Netherlands that have big manufacturing and pharma centres, a lot of research and development, who were pushing for it." The new rules would attempt to reconcile the issue of regulatory data protection, which theoretically encourages pharmaceutical companies to invest more in life-saving medicines, with the need to make drugs more affordable. Under existing EU rules, pharma companies were entitled to keep clinical data for eight years - the so-called regulatory data protection (RDP) before they were obliged to make it accessible. After the eight years was up, generic producers could file an application to use the data, at which point the patent holder enjoyed a further two - and sometimes three - extra years of protection. Under the commission's 2023 proposal, there would be a two-year reduction in the baseline RDP to six years, with an extra two years of protection. However, pharma companies could claw back a further two years of protection - extending RDP to ten years. The ten-year protection period would be available if the patent holder won approval for significant new innovations (one extra year of protection), if the product addressed an "unmet medical need", ie, where there was product authorised in the EU for a particular disease, or where the disease was associated with a high death-rate (such a situation would merit an extra six months of market protection), or if the manufacturer conducted clinical trials or extended access to all member states (another six months). Essentially, the commission was attempting to balance the need to reward medicines that meet the greatest clinical need, while speeding up access to generic producers who will make drugs that are cheaper. However, the new rules were facing hostility from traditional pharma manufacturing countries such as Germany, France, Denmark and the Netherlands, who argued that a shorter clinical data protection period would stymie research. The Irish Times reported on a full scale lobbying effort by industry, including a claim in a letter to Tánaiste Simon Harris by the Irish Pharmaceutical Healthcare Association (IPHA) that the proposal could lead to a 22% drop in new medicines being developed over the coming decade. It is understood there were tensions between the IDA and Enterprise Ireland, who shared the concerns of industry, and the Department of Health, which was more concerned with lowering the cost of medicines and making them more accessible. A number of sources have said that while member states with important pharma sectors went public two years ago, when the commission first proposed reducing clinical data protection from eight years to six, in demanding the status quo of eight years, Ireland remained on the fence, and did so right up until a key meeting of EU ambassadors on 21 May. On that date, Ireland joined a blocking majority of ten countries - including Belgium, Denmark, the Netherlands and Germany - to oppose the latest Polish proposal that would have essentially increased the RDP by one year to seven, but short of eight. As a result of that blocking minority, the Poles came back with another compromise text, which is - to all intents and purposes - a return to eight years, with various caveats and conditions designed to make medicines cheaper and more accessible (one part of the text aims to ensure that medicinal products are available in all member states and provides for regulatory action if the marketing authorisation holder does not comply). Officials say the text provides more reassurance for generic producers, and will cut timelines for authorised medicines to get to market. There are other measures, including making it easier to have multi-country and multilingual medicine packs, which should reduce production costs and make it easier to move medicines around Europe. At yesterday morning's meeting of EU ambassadors, the new text received overwhelming support. The IPHA are understood to be broadly satisfied with the compromise. In a statement, the organisation said it "believes the [member states] position represents a more balanced approach than had originally been proposed by the Commission. "As the legislative process enters the final phase, EU decision makers must continue to find solutions that will keep Europe competitive through a predictable and globally competitive environment for research, development and manufacturing, while ensuring fairer access to innovative medicines for patients across the EU." Support is not uniform. The chief executive of the Confederation of Danish Industry Lars Sandahl Sørensen accused member states of triggering a potential flight of European industry to Trump's America. "We are de facto making the EU's pharmaceutical industry less competitive and thus European society vulnerable," he said. The European pharma lobby group EFPIA described yesterday's position by member states as "a missed opportunity to position Europe's life sciences sector at the forefront of global competition". In a statement, EFPIA said: "The choice to reduce intellectual property protections for pharmaceutical companies makes Europe less attractive, discouraging investment and jeopardising the development of innovative treatments in Europe without addressing the underlying barriers and delays to patient access." There is some scepticism over the industry's seeming exploitation of Donald Trump's persistence in threatening tariffs on European pharmaceutical exports and reshoring manufacturing to the US. In April the industry wrote to commission president Ursula von der Leyen, suggesting that €50.6 billion in capital investment and €52.6bn in research and development expenditure were at risk if the EU continued to over-regulate the pharma sector. "Unless Europe delivers rapid, radical policy change then pharmaceutical research, development and manufacturing is increasingly likely to be directed towards the US," EFPIA warned. Officials suggest the upcoming Critical Medicines Act (CMA) will further boost access to cheaper medicines. Drugs such as those for diabetes or HRT have been susceptible to disruption and shortages in recent years because they are often generic and produced outside the EU. The CMA will aim to encourage more manufacturing of such drugs in Europe. The action now moves to the European Parliament, where so-called trilogues - three way negotiations between member states, the Commission and MEPs - will further shape the legislation. Last year the parliament adopted its own position, calling for an RDP of seven and a half years with the possibility of some extensions. The parliament has since moved to the right, following last year's elections, so it remains to be seen if further battles are expected.
Hindustan Times
28-05-2025
- Health
- Hindustan Times
Haryana tightens noose on illegal abortions: 3 medical shops sealed, 6 FIR's registered in a week
Intensifying crackdown on the illegal sale of medical termination of pregnancy (MTP) kits, Haryana authorities have seized 1,787 kits from seven districts in the last week—May 20-26, tightening surveillance and enforcement to curb misuse of abortion drugs. After the state task force was set up on February 6 to improve Haryana's sex ratio at birth (SRB) under the flagship Beti Bachao-Beti Padhao campaign, authorities have seized about 8,800 MTP kits, registered over 50 FIRs, including at least 18 against online sellers of the kits. As the crackdown is part of Haryana's broader strategy to prevent sex-selective abortions through coordinated monitoring, Food and Drugs Administration (FDA) registered six first information reports (FIRs) in the last week alone, sealed three medical shops, and two medical firms were served notices under the Drug and Cosmetics Rules, 1945, for regulatory violations, according to official data. The violations under the MTP Act are punishable with rigorous imprisonment ranging from two to seven years. These offences are cognisable, non-bailable and non-compoundable. The largest seizure was reported from Yamunanagar, where 1,740 kits were recovered from a distributor operating in Professor Colony. The remaining seizures were made in Gurugram (6), Ambala (1), Palwal (3), Panipat (20), Jind (13), and Rewari (4). 'During inspection at Dezire distributors in Yamunanagar, FDA officials found 1,740 Rule 96 of the Drugs Rules,1945. Of these, 40 kits were taken for testing and analysis, while the rest were sealed,' Manmohan Taneja, state drug controller of Haryana said. 'Prosecution under the Drugs and Cosmetics Act will be launched after following due procedure. The FDA is vigorously going after those involved in this racket of selling MTP kits illegally. Ever since the crackdown was launched, over 50 people have been booked for illegal sale of MTP kits.' As part of the intensified drive, the number of wholesale dealers selling MTP kits has been slashed from 32 to just six within a month. Officials said 373 MTP kits were sold last week to registered MTP centres in the state by six wholesalers, marking a declining trend in the legal sales of these kits. In a parallel enforcement effort during the previous week (May 13–19), the authorities conducted 50 inspections, closed 25 MTP centres, registered three FIRs, and seized 921 MTP kits. Licences of two doctors—one in Kurukshetra and another in Assandh (Karnal)—were suspended for malpractice and guideline violations. To check illegal abortions and protect the rights of the girl child, the additional chief secretary (ACS-health and family welfare) Sudhir Rajpal has also launched a personalised support system. Over 50,000 pregnant women with one or more daughters have been assigned an ASHA or anganwadi worker as a SAHELI (companion) for counselling and close monitoring. Any suspicious abortion in such cases will trigger an investigation and accountability of the SAHELI involved, top government officials said. Meanwhile, on Tuesday, Rajpal reviewed the steps being taken by the STF set up in February to monitor progress achieved in curbing illegal abortions under the flagship 'Beti Bachao-Beti Padhao' campaign. The ACS directed officials to hold senior medical officers accountable in all community health centres (CHOs), ensuring that no illegal abortions occur within their jurisdictions. Henceforth, SMOs will hold weekly meetings with medical officers and CHOs every Tuesday, while chief medical officers were directed to hold meetings with SMOs every Wednesday to review efforts against illegal abortions and improve the sex ratio.
Time of India
21-05-2025
- Health
- Time of India
FDA shuts 16 stalls, destroys items worth Rs 1.3L at Sanguem feast
Panaji: In a major raid at Sanguem, the directorate of Food and Drugs Administration (FDA) shut down 16 food stalls operating without licences and involved in the unhygienic preparation of food items at the Sanguem Purumentachem feast. They destroyed 100 bottles of expired sauces used in the preparation of food. Stock worth Rs 1.3 lakh of ice gola concentrate, tomato sauce, green chilli sauce, and manchurian sauce was destroyed due to violations related to labelling and storage. The FDA discovered that gobi manchurian was being made and sold in "extremely unhygienic conditions, using expired sauce", which created a serious health hazard for consumers. 'Ice golas were being made using non-edible and unclean ice, making them unsafe for human consumption,' the FDA said. During the raid, approximately 100 bottles of expired sauces were seized and immediately disposed of along with the contaminated ice used in ice golas. Samples of gobi Manchurian and gobi Manchurian sauce were collected and sent for analysis. 'All the food vendors were directed to maintain hygiene and obtain proper licenses, failing which, stringent action will be taken,' the FDA stated. The raid was conducted by senior food safety officer Rajiv Korde and food safety officers Priya Komarpant and Swapnil Faterpekar.
Time of India
06-05-2025
- Health
- Time of India
Sangli FDA disposes of 30,000 litres of adulterated milk
Kolhapur: Food and Drugs Administration (FDA) officials in Sangli disposed of 30,400 litres of adulterated milk worth Rs 10.64 lakh on Sunday night after it tested positive for salt contamination. The action followed a quality-check campaign where nine milk tankers were inspected at Nagaj Phata along the Nagpur-Ratnagiri national officials said the milk was bound for a Kolhapur processing plant. "FDA officials detected salt adulteration in a milk tanker using rapid testing strips. It was found that the milk contained a significant proportion of sodium chloride. The milk was disposed of on-site, and samples were sent to a laboratory for further testing. Once the report is received from the laboratory, a case will be filed against the supplier," Assistant commissioner of FDA N S Masare salt-adulterated milk poses health risks, particularly for those with high blood pressure. The tanker was carrying milk from a Solapur district chilling centre. "If lab tests confirm significant adulteration, the supplier may face jail time (6 months to 5 years); otherwise, s/he may be fined Rs 5 lakh," an FDA official to the official, salt is added to milk to artificially boost its solid content, masking dilution and allowing suppliers to charge higher rates, as milk prices are determined by solid and fat content. "Excessive salt in milk can cause nausea and gastroenteritis. It can also contribute to hypertension or kidney issues, especially if consumed regularly," the official Food Safety and Standards Authority of India (FSSAI) states that milk should not contain added salt, as it compromises safety and quality.
