Latest news with #DrugsandCosmeticsRules
Mint
5 days ago
- Health
- Mint
India's booming beauty industry has a serious problem of quality. New rules target this menace
New Delhi: India has tightened rules to ensure stricter testing and labelling of cosmetics to enhance safety, check counterfeit products and clearly define spurious items, said two officials aware of the development. A failure to comply with the new rules introduced by the health and family welfare ministry will result in the suspension and cancellation of licences, according to the officials cited earlier and documents reviewed by Mint. The Cosmetics (Amendment) Rules, 2025 were finalized and notified on 29 July after a detailed consultative process with the relevant stakeholders and further consultation with the Drugs Technical Advisory Board, a top drug advisory panel, said the first official quoted earlier. The changes include setting up a dedicated Central Cosmetics Laboratory to test products before they hit the shelves. India's cosmetics market—including skin, hair and oral care, fragrances, and colour products—is estimated at $20 billion, growing at an annualized rate of 25%, according to India Brand Equity Foundation. New brands have been mushrooming as rising incomes spur consumption. However, that also brought a myriad of new products claiming to provide unverified benefits, especially when peddled by celebrities and influencers. Stricter rules aim to curb exaggerated claims and ensure higher standards that will also benefit exports. "The cosmetic industry in India is largely under-regulated, particularly concerning product claims. Unlike in many other countries, companies here can make unsubstantiated assertions—such as promising to make a person several shades fairer or claiming to stop hair fall—that are often misleading,' said Dr Dinesh Kumar Devaraj, president, Indian Association of Dermatologists, Venereologists & Leprologists (IADVL), Tamil Nadu. 'This is where regulatory checks are critically needed.' Queries sent to the health ministry spokesperson and cosmetic manufacturers, including Hindustan Unilever Ltd, on Friday remained unanswered. Cosmetics in India are regulated under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body responsible for implementing the rules. 'Lots of clerical and administrative corrections have been made in cosmetics rules,' the first official quoted earlier said. 'These comprehensive measures signal a serious commitment by the government to prioritize consumer safety and bring greater transparency to India's cosmetics industry.' Manufacturers will now have to keep detailed records of all raw materials and manufactured batches for three years or six months after the batch expires, whichever is later. This improved record-keeping will significantly enhance the traceability of products in case of a safety concern. The new regulations require that labels on cosmetics to be exported meet the legal standards of the destination country. A cornerstone of the new policy is the Central Cosmetics Laboratory to test samples. It will also be an appellate laboratory, ensuring a centralized and rigorous approach to product quality. The rules, for the first time, empower the State Licensing Authority to suspend or cancel a license if a company fails to comply with any of its conditions or with any provision of the Act or the rules. This order will be issued in writing after giving the licencee an opportunity to show cause and be heard. However, a manufacturer whose licence is suspended or cancelled has the right to appeal the decision to the state government within 90 days, ensuring due process is followed. The new regulations specifically define 'spurious cosmetics' under section 17D of the Act, strengthening the government's ability to crack down on counterfeit items. That provides a stronger legal basis for regulatory bodies to crack down on such items. The rules also seek to streamline international trade. 'The cosmetic is meant for export, then the label on the package or container of cosmetic shall comply with the law of the country to which the cosmetic is to be exported,' the notification said. Similarly, a specific provision has been added to allow for a code number instead of the manufacturer's name and address on the label if the importer requires it. These changes are designed to protect consumers from unsafe and counterfeit cosmetic products while strengthening the regulatory framework, the second official quoted earlier said. According to the L'Oréal India spokesperson, the updated cosmetic regulations enhance clarity and compliance, '…particularly the provision for export labelling, which significantly streamlines international trade, benefiting our exports from India to 25 countries'. Citing that 95% of its products sold in India are locally manufactured, the spokesperson said these 'progressive changes further support our 'Make in India' endeavors and our mission to provide high-quality beauty solutions both domestically and internationally'. The industry has also come under scrutiny after complaints regarding mercury-based products, Mint reported earlier. Products such as skin-lightening creams, 'anti-ageing solutions' for freckles and dark spots and certain makeup items are known to contain the toxic element. Dr. Devaraj said another concern is the misuse of steroids in cosmetics for skin brightening, which can lead to significant dermatological damage. 'As a doctor, I can easily distinguish between skin that has been brightened by such steroid use and skin that is healthy,' he said. 'The issue of wrong or non-existent labelling also needs to be addressed. Furthermore, there is a complete lack of regulation on pricing, which allows for a dramatic disparity in costs for similar products.' The validation provided by celebrities and social media influencers heavily influences consumers, especially first-time buyers, according to him. 'Given our vast population, a small fraction of buyers can generate significant profit for a company, reducing the need for repeat business,' said Dr. Devaraj. 'This trend has been amplified by the rise in online sales and paid promotions post-Covid.'
Time of India
7 days ago
- Health
- Time of India
Mumbai police order CCTV cameras at medical stores in a month to curb illegal drug sales
Mumbai: To check illegal sale of scheduled drugs, the Mumbai police has asked all pharmacy stores to install CCTV cameras in their premises within a month. Owners of medical stores and chemist shops are unhappy with the move as they believe such measures will not help. Scheduled drugs refer to medications regulated under the Drugs and Cosmetics Rules, 1945, on the basis of how they are manufactured, stored, distributed, and prescribed. For instance, Schedule H includes prescription drugs that cannot be sold without a doctor's prescription and Schedule X refers to prescription drugs that are highly addictive You Can Also Check: Mumbai AQI | Weather in Mumbai | Bank Holidays in Mumbai | Public Holidays in Mumbai The directive, issued under Section 152 of the Indian Civil Security Code, 2023, by deputy commissioner of police (anti-narcotics cell) Navnath Dhawale, is based on intelligence inputs. The Narcotics Control Bureau (NCB) and the Commission for Protection of Child Rights, New Delhi, too, had recently raised concerns about the sale of scheduled drugs and inhalants without valid prescriptions. The Anti-Narcotics Cell and Food and Drug Administration (FDA) found several medical stores in Mumbai sold habit-forming drugs without maintaining proper records. According to the order, every medical shop in Mumbai and its suburban districts will have to install CCTV cameras at all entrances, exits, and sale counters in such a way that the faces of customers and transactions are recorded. The cameras must have a minimum resolution of 2 megapixels, and footage must be stored for at least one month. Officials from the District Drug Control Authority and Child Welfare Police Officers can inspect CCTV footage. Medical shop owners have been given a 30-day period to comply with the order. Senior officials said the initiative is part of a larger crackdown on the misuse of prescription drugs, often diverted into the narcotics trade. Abay Pandey, president of the All Food and License Holders Foundation, told TOI: "Firstly, the police have no powers to check medical stores if there are not accompanied by FDA officials. Secondly, these CCTV cameras won't serve any purpose as the prescriptions and medicine strips are written in small fonts. How is the camera going to help them?" Prasad Danave, president of Retail and Dispensing Chemist Association Mumbai, said, "How is the camera going to keep a tab on the medicines sold? What about the online sites that sell abortion pills to a 14-year-old girl? Is there any check on them?"
Business Upturn
31-07-2025
- Business
- Business Upturn
MedPlus Health arm receives drug license suspension orders for Telangana stores
By Aditya Bhagchandani Published on July 31, 2025, 19:03 IST MedPlus Health Services Limited has informed exchanges that its subsidiary, Optival Health Solutions Private Limited, has received two suspension orders pertaining to drug licenses for its retail outlets in Telangana. According to the regulatory filing dated July 31, 2025, the Drug Control Administration, Warangal, issued the following suspension orders: Store at Station Ghanpur : License suspended for five days : License suspended for Store at Girinigadda Main Road, Jangaon: License suspended for three days These actions were taken under Rule 65 of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The orders were received on July 30, 2025. Financial Impact The suspension is expected to result in: An estimated revenue loss of ₹0.98 lakh from the Station Ghanpur store from the Station Ghanpur store A ₹0.40 lakh loss from the Girinigadda store The company clarified that while the impact is minimal and localized, it is fully cooperating with the authorities to comply with all regulatory directives. The announcement has been made public in compliance with SEBI disclosure norms and is available on the MedPlus website and stock exchange portals. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Mint
28-07-2025
- Business
- Mint
Centre to rope in states to enforce drug quality norms
New Delhi: The Drug Controller General of India (DCGI), is set to instruct states and Union territories to identify and take action against drugmakers failing to adhere to Good Manufacturing Practices (GMP), according to two official familiar with the matter. GMP is meant to ensures consistent production and quality control, vital for patient safety, product effectiveness, and preventing fake drugs. A recent revision of Schedule M GMP rules seeks to align India's quality standards with global benchmarks in a bid to boost the country's reputation as a reliable drug producer. All large companies, with revenues exceeding ₹ 250 crore, are implementing GMP while smaller firms received an extension until 31 December to make the necessary upgrades. 'Those who have applied to implement GMP and upgrade their facility have got time till December. Now state governments have to verify the compliance of those companies who have not applied. Now, DCGI may issue some direction to the State/UTs to look into this matter and identify non-compliance firms,' said the official. 'The matter was also discussed sometime back involving officials from Niti Aayog, pharma associations and Central Drugs Standard Control Organization (CDSCO),' the second official said. About 8,500 of India's 10,000 pharma companies are small businesses, concentrated in Maharashtra, Gujarat, Himachal Pradesh, and Andhra Pradesh. Only 2,000 of these MSMEs currently have GMP certification from the World Health Organization. According to government estimates, the Indian pharmaceutical market was valued at an estimated $50 billion in FY 2023-24, with domestic consumption accounting for $23.5 billion. Globally, India's pharmaceutical industry stands as the third largest by volume and the 14th largest by value, being the foremost supplier of generic drugs worldwide, contributing approximately 20% of the global supply. This encompasses the production of around 60,000 generic brands across 60 therapeutic categories. Key segments within this robust industry include generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars, and biologics. In 2023, the government revised Schedule M of the Drugs and Cosmetics Rules, 1945, making new GMP standards mandatory for drug manufacturers. This initially applied to companies with an annual revenue of ₹ 250 crore and above, and has now been extended to MSME drug firms. This was prompted by incidents of contaminated Indian cough syrups leading to child deaths in the Gambia and Uzbekistan two years ago. Harish Jain, President of the Federation of Pharmaceutical Entrepreneurs (FOPE), stated that Micro, Small, and Medium Enterprise (MSME) drug firms that requested an extension from the drug regulator to implement Good Manufacturing Practice (GMP) compliance are actively upgrading their facilities within the agreed timeframe. He added that any firms not seeking an extension are presumed to be already adhering to the GMP protocols. Dr R.V. Asokan, former president of the Indian Medical Association (IMA) said that as the Indian pharma industry began growing exponentially in the last 25 years, the power to approve drugs was delegated from the Central Drug Authority (CDA) to the state drug authorities. Small states like Uttarakhand and Himachal Pradesh benefitted from business-friendly regulations and GMP was not enforced strictly. "Because of lack of infrastructure and human resources quality assurance is less than satisfactory. The deficiencies, due to the lack of GMP regulations may differ from one company to another. These gaps could be around storage, manufacturing, waste management, ventilation and infrastructure at the pharma units,' he added. Queries sent to the health ministry remained unanswered till press time.
India Today
11-07-2025
- Health
- India Today
Health Ministry advisory: Doctor's prescription must for ‘Red Line' antibiotics
The Ministry of Health and Family Welfare, Government of India, has reiterated that medicines bearing a Red Line mark should not be consumed without a valid doctor's prescription. The advisory was issued in the context of growing concerns around antimicrobial resistance (AMR) and the misuse of antibiotics by the LINE CAMPAIGN LAUNCHED TO COMBAT ANTIBIOTIC MISUSETo create public awareness around the responsible use of antibiotics and prescription drugs, the Ministry launched the Red Line Campaign on Antibiotics. This initiative urges citizens to identify medicines marked with a red vertical line on the packaging and to avoid their consumption without medical medicines typically include antibiotics and certain scheduled drugs categorised under Schedule H and H1 of the Drugs and Cosmetics Rules, 1945, which are legally permitted to be sold only on prescription by a Registered Medical Practitioner. 'Medicines with a red line should NEVER be consumed without medical advice. "Misuse of antibiotics can lead to antibiotic resistance,' the Ministry stated in an official ANTIMICROBIAL RESISTANCE SURVEILLANCE NETWORK (NARS-NET) To strengthen surveillance, the Government of India has established a National AMR Surveillance Network (NARS-Net). Under this network:AMR surveillance of 9 priority pathogens is carried out from identified clinical covers defined drug-bug combinations by the programme's Standard Operating Procedures (SOPs).Annual reports analysing surveillance data from 2017 to 2023 are available at PROGRAMME ON AMR CONTAINMENTThe Ministry is implementing the National Programme on Antimicrobial Resistance (AMR) Containment to address the emerging challenge of antibiotic resistance in India. Key components of the programme include:Awareness activities conducted annually during World Antibiotic Awareness Week (WAAW) for healthcare workers and the general Education and Communication (IEC) materials including posters, videos, and radio jingles, focused on:Judicious use of antibioticsPreventing infections through hand hygieneIEC content has been developed in 12 regional languages and shared with States and GUIDELINES AND POLICY INTERVENTIONSThe Ministry has also issued several guidelines to promote rational use of antibiotics:National Treatment Guidelines for Antimicrobial UseGuidelines on Infection Prevention and Control (IPC) to reduce healthcare-associated infections and limit unnecessary antibiotic prescriptions(Access at: FOR AMR SURVEILLANCE AND AWARENESSThe Government has steadily increased budgetary allocations to support AMR containment:666.89 lakhs in 2021–22777.81 lakhs in 2022–23919.00 lakhs in 2023–24These funds are utilised for laboratory surveillance, training, communication campaigns, and infection control ON PUBLIC KNOWLEDGE CONDUCTED BY ICMRadvertisementThe Indian Council of Medical Research (ICMR), in collaboration with AMR surveillance partners, has conducted nationwide surveys and studies to assess public awareness and understanding of AMR. These findings are used to refine strategies and address knowledge IS URGED TO #READTHERED AND USE MEDICINES RESPONSIBLYThe Ministry of Health continues to appeal to all citizens to be vigilant while purchasing and consuming medicines. The public is advised to:Always check for the red line on medicine self-medication and consult a licenced medical the full course of antibiotics if prescribed.'The red line on medicines is a warning, not a decoration. Be responsible. #ReadTheRed.'This information was shared in a written reply by the Union Minister of State for Health and Family Welfare, Shri Prataprao Jadhav, in the Lok Sabha.- Ends
