Aug 14,2024 The Karnataka drugs control department, which ranks third in the country for total implementation of the Drugs and Cosmetics Act & Rules behind Maharashtra and Gujarat, aims to attain the top spot, Karnataka Drugs Controller in-charge Dr Umesh Shantharaj said. “Our state has been in the third position for a while and now my vision is to move up the ladder and take the top slot. The need of the hour is to raise the bar in enforcement of drug regulations and ensure high quality standards of medicines. There is no reason why Karnataka should lag behind in drug enforcement. We need to become No. 1,” he added. The biggest responsibility of a regulator is to ensure the safety, efficacy and high quality of the medicines reach the patients at a cost fixed by the National Pricing Control Authority (NPPA), he stated. Taking charge on August 1, Dr Umesh told Pharmabiz that he is entrusted to oversee all the functions of the state drugs control department spanning from enforcement, drug testing laboratory, Board of Control for Examination Authority. Reaching the top spot in the country for regulation adherence will indeed be challenging but a worthwhile endeavour to elevate Karnataka’s performance. Revised Schedule M on par with WHO-GMP is critical for this industry which is recognised as the Pharmacy of World. The task on hand is to inspect the large manufacturing units for which the deadline was July 5, 2024 to ensure that they are compliant and ensure total adherence by MSMEs for which the last date is December 27, 2024, he said. Then there is an impending shortfall of drug inspectors (DIs) as their recruitment decision is with the Supreme Court. DIs are the heart of the drugs control department. Yet with a handful of enforcement officers, our team is carrying out the required surprise checks for not-standard quality (NSQ) drugs and raising flags on violations to the D&C Act which is commendable. Current shortfall of DIs are 5 as against the total sanctioned posts of 112. In fact, there were 11 inspectors and six were promoted as assistant drugs controllers. We are in talks with health minister Dinesh Gundu Rao to look into this. Once the required DIs are inducted, our department will go full throttle in inspections across the 31 districts, he said. There is a visible lack of investments in pharmaceuticals and as the drugs controller in-charge, meetings will be held with the industry to ascertain reasons for not being able to attract global big ticket investments. It is of prime importance for our department as the state regulatory authority to be with the industry as only working together will enable us to help Karnataka pharma sector progress, Dr Umesh said. Every effort to interact with the government on industry issues are on. The 2022 move to form a committee for the Pharma Park will be re-ignited as this file is pending with the government and therefore the process is easier. Karnataka also needs a NIPER at Bengaluru which is justified as the state already home to 388 pharmacy colleges with an impressive line-up of the related industries. Also we will ensure that no MSMEs will shut down as the drugs control department will extend the much-needed guidance to implement the revised Schedule M, he said. On a concluding note, Dr. Umesh said that manufacturers are cooperative with the state regulatory authority. This is the only state where the adherence is total making us in top three in the country because the industry is responsible not to deviate regulations to keep their image intact. Source: Pharmabiz

August 12,2024 Mumbai: Atul Bioscience Ltd received establishment inspection report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility situated in Ambernath, Maharashtra. The EIR was issued post the last inspection of the facility conducted from May 06, 2024, to May 10, 2024 which concluded with zero FDA 483 observations. The company is engaged in manufacturing and marketing of active pharmaceutical ingredients (APIs), their intermediates and contract manufacturing operations. Dr Prabhakar Chebiyyam, Managing Director, ABL, said, “The successful completion of this inspection reflects the dedication and hard work of our entire team. It strengthens our resolve to deliver high-quality pharmaceutical products consistently and further improve our processes to meet the ever-evolving needs of the global pharmaceutical industry.” Source: Pharma

August 13,2024 New Delhi: All Indian salt and sugar brands, whether big or small, packaged or unpackaged, contain microplastics, according to a study published on Tuesday. The study, titled “Microplastics in Salt and Sugar” and conducted by the environmental research organisation Toxics Link, tested 10 types of salt — including table salt, rock salt, sea salt and local raw salt — and five types of sugar purchased from both online and local markets. The study revealed the presence of microplastics in all salt and sugar samples, in various forms, including fibre, pellets, films and fragments. The size of these microplastics ranged from 0.1 mm to 5 mm. The highest levels of microplastics were found in iodised salt, in the form of multi-coloured thin fibre and films. Toxics Link founder-director Ravi Agarwal said, “The objective of our study was to contribute to the existing scientific database on microplastics so that the global plastic treaty can address this issue in a concrete and focused manner.” “We also aim to trigger policy action and attract researchers’ attention to potential technological interventions that could reduce exposure risks to microplastics.” Toxics Link associate director Satish Sinha added, “Our study’s finding of substantial amounts of microplastics in all salt and sugar samples is concerning and calls for urgent, comprehensive research into the long-term health impacts of microplastics on human health.” The concentration of microplastics in the salt samples ranged from 6.71 to 89.15 pieces per kilogramme of dry weight, the report said. Iodised salt had the highest concentration of microplastics (89.15 pieces per kilogramme) while organic rock salt had the lowest (6.70 pieces per kilogramme), according to the study. In sugar samples, the concentration of microplastics ranged from 11.85 to 68.25 pieces per kilogramme, with the highest concentration found in non-organic sugar. Microplastics are a growing global concern because they can harm both health and the environment. These tiny plastic particles can enter the human body through food, water and air. Recent research has found microplastics in human organs such as the lungs, heart, and even in breast milk and unborn babies. Previous studies found that the average Indian consumes 10.98 grams of salt and around 10 spoons of sugar every day — much higher than the World Health Organization’s recommended limits. Source: Healthworld

August 14,2024 New Delhi: Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing. Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc’s Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE. Source: Pharma

August 13,2024 Mumbai: A sperm or egg donor has no legal right on the child and cannot claim to be its biological parent , the Bombay High Court held on Tuesday while allowing a 42-year-old woman visitation rights to her five-year-old twin daughters. The woman, in her plea, said her daughters, born via surrogacy, were living with her husband and younger sister, who was the egg donor. The petitioner’s husband had claimed since his sister-in-law was the egg donor, she had a legitimate right to be called a biological parent of the twins and that his wife had no right over them. A single bench of Justice Milind Jadhav, however, refused to accept this contention, citing that though the petitioner’s younger sister was the egg donor, she has no legitimate right to claim that she is a biological parent of the twins. The court said the role of the younger sister is that of an egg donor, rather, a voluntary donor, and at the most, she may qualify to be a genetic mother and nothing more. An advocate appointed to assist the court in the matter informed it that since the estranged couple’s surrogacy agreement took place in 2018 when the Surrogacy (Regulation) Act 2021 had not come into force, the guidelines issued by the Indian Council of Medical Research (ICMR) in 2005 would regulate the agreement. As per a rule of the guidelines, the donor and the surrogate mother have to relinquish all parental rights, the court noted, adding that in the present case, the twins would be the daughters of the petitioner and her husband. “Under the guideline, it is clearly stated that the sperm/oocyte (egg) donor shall not have parental rights or duties in relation to the child and in that view of the matter, the younger sister of the petitioner can have no right whatsoever to intervene and claim to be the biological mother of the twin daughters,” the high court said. As per the plea, the couple could not conceive naturally, and the petitioner’s sister volunteered to donate her eggs. In December 2018, the babies were conceived by a surrogate woman and the twin girls were born in August 2019. In April 2019, the sister and her family met with a road accident, and her husband and daughter were killed. The petitioner lived with her husband and twin daughters from August 2019 to March 2021. Following a marital discord in March 2021, the husband moved into another flat with the children without informing his wife. The man claimed that his wife’s sister (the egg donor) had been depressed after the road accident and started living with him to take care of the twins. The petitioner filed a police complaint and an application before a local court, seeking interim visitation rights to her daughters. The local court rejected her application in September 2023, following which she approached the high court. The wife said her sister had only donated her eggs and was not the surrogate mother, and hence, she had no legal right or role in the lives of the twins. The high court, in its order, noted that the surrogacy agreement of 2018 between the intending parents, the surrogate mother and the doctor is signed by the petitioner, her husband and the doctor. “It is seen that the petitioner (wife) and Respondent No. 1 (husband) are recognised as the intending parents. At least to a naked eye, there is no ambiguity whatsoever while observing and even concluding that it is the petitioner along with Respondent No. 1 who signed the surrogacy agreement as intending parents,” it said. Justice Jadhav held that the lower court order denying visitation rights to the wife was passed without proper application of mind and is unsustainable and quashed it. The court directed the husband to give physical access and visitation rights of the twins to the petitioner for three hours every weekend. Source: Healthworld

August 14,2024 New Delhi: The division bench of the Delhi High Court has asked its single judge bench to expeditiously decide afresh a Mankind Pharma’s plea seeking to restrain Chandra Mani Tiwari and others from adopting and using the name Mercykind Pharmaceuticals. A bench led by Justice Yashwant Varma said that “although we are informed that during the pendency of the present appeal, the defendant (Tiwari) has made significant changes both in its logo and get up of products which are being marketed by it, in our considered opinion, these and other issues which arise would clearly merit consideration afresh by the learned single judge.” The HC noted that the issue which required consideration was that of “dishonest adoption” by the erstwhile employee. Mankind Pharma alleged that Tiwari, who was working with it as a marketing manager till January 2015, had incorporated a company under the name Mercykind Pharmaceuticals. Contesting the use of the suffix “Kind” by Tiwari, the pharma company submitted that it had adopted ‘Mankind’ as a trademark in 1986, and holds as many as 157 trademarks with the suffix ‘Kind’. Besides, Mankind said it has revenues over Rs 4000 crore and has a turnover of Rs 7000 crore. However, the single judge had in 2018 refused to grant any temporary injunction against Tiwari. Source: Pharma

July 28,2024 New Delhi: The lowering of custom duty on x-ray tube and flat panel detectors, key components of a digital x-ray machine, is unlikely to reduce the cost of imaging. Industry sources have told TOI that the move is aimed at spurring domestic manufacturing of the machine which is used extensively in hospital settings to detect bone fractures, pneumonia and dental problems among others and, thus, reduce the cost of x-ray in the long run. “These revised rates are expected to positively impact the x-ray machine industry by enhancing component availability at lower costs. This change is anticipated to boost the domestic medical device sector, contribute to component availability at lower costs and reduced healthcare costs, making advanced medical imaging more accessible and affordable,” said a government official. Currently, most of the digital x-ray machines are imported as a whole or in parts and then assembled in the country. Government sources said a Phased Manufacturing Programme (PMP) was notified by the department of pharmaceuticals on Jan 22, 2021, to promote domestic manufacturing of medical x-ray machines and specified sub-assemblies /parts / sub-parts whereby tariff changes at an increasing rate were proposed in a phased manner. However, a source said, the industry represented before the department of pharmaceuticals that manufacturing capacity for x-ray tubes and flat panel detectors is yet to develop in the country and requested for revision in the PMP schedule relating to these items. “In this regard, after careful examination, it was found that it may take at least two years before sufficient domestic capacity is established for x-ray tubes and flat panel detectors to meet the domestic requirement. Thereafter, the department of pharmaceuticals requested the revenue department for revised rates which has been done now.” “Currently, digital x-ray machines being imported from the US and China cost anywhere between Rs 18 lakh to over a crore. If the domestic manufacturing is successful, the same machines can be manufactured at much lesser cost which will eventually lead to reduction of imaging using this device. Also, it may become more feasible to ensure wider availability of x-ray machines, including at the primary health centres spread across the country,” Dr Harsh Mahajan, chairman and founder of Mahajan Imaging, who is also the chairman of FICCI’s health services committee said. Ashutosh Raghuvanshi, MD and CEO of Fortis healthcare, said the government’s move to revise custom duty on key components of x-ray machines will foster local manufacturing. However, he added, some long standing healthcare sector demands remain unaddressed in the current budget. “These include increasing the expenditure on healthcare to 2.5% of the GDP,” Raghuvanshi said. Source: Healthworld

July 28,2024 New Delhi, The Delhi High Court on Wednesday dismissed a woman’s petition seeking recovery of Rs 30 lakh she claimed to have given to a man to secure her daughter’s admission to the All India Institute of Medical Sciences (AIIMS), saying seats in the MBBS course at one of the premier institutes of medicine were not for sale. Refusing to grant any relief to the woman, Justice Jasmeet Singh observed that the woman herself “perpetuated an illegality” and law did not recognise contracts having an object that is unlawful, immoral and against public policy. “It is a known fact that the AIIMS is one of the most premier institutes of medicine in India. Children spend hours and hours preparing for the entrance in AIIMS. The seats in MBBS course at AIIMS are not for sale. Appellant may be gullible but court can’t come to the assistance of a person who has perpetuated an illegality,” said the court. The woman had moved the high court in appeal against a lower court order rejecting her lawsuit for recovering Rs 30 lakh from the man who allegedly lured her into giving the money to secure a seat for her daughter claiming to have “contacts” with the health minister and officials at the institute. The court observed that students desirous of seeking admission in AIIMS studied 18 hours a day and the appellant tried to “jump the queue” by cheating. “If by paying Rs 40 lakh you are able to get a seat, what is going to happen to our country?.. The facts of the case paint an abysmal picture,” the court said and held that there was no illegality in the lower court order. Source: Healthworld

Nov 30,2024 New Delhi, The Delhi High Court on Wednesday dismissed a woman’s petition seeking recovery of Rs 30 lakh she claimed to have given to a man to secure her daughter’s admission to the All India Institute of Medical Sciences (AIIMS), saying seats in the MBBS course at one of the premier institutes of medicine were not for sale. Refusing to grant any relief to the woman, Justice Jasmeet Singh observed that the woman herself “perpetuated an illegality” and law did not recognise contracts having an object that is unlawful, immoral and against public policy. “It is a known fact that the AIIMS is one of the most premier institutes of medicine in India. Children spend hours and hours preparing for the entrance in AIIMS. The seats in MBBS course at AIIMS are not for sale. Appellant may be gullible but court can’t come to the assistance of a person who has perpetuated an illegality,” said the court. The woman had moved the high court in appeal against a lower court order rejecting her lawsuit for recovering Rs 30 lakh from the man who allegedly lured her into giving the money to secure a seat for her daughter claiming to have “contacts” with the health minister and officials at the institute. The court observed that students desirous of seeking admission in AIIMS studied 18 hours a day and the appellant tried to “jump the queue” by cheating. “If by paying Rs 40 lakh you are able to get a seat, what is going to happen to our country?.. The facts of the case paint an abysmal picture,” the court said and held that there was no illegality in the lower court order. Source: Healthworld

July 30,2024 New Delhi: Drug manufacturers are likely to face increasing scrutiny of their branding practices, as the government plans to crack down on lookalike and soundalike brand names of medicines that it believes cause confusion and pose serious risk to patient safety. According to people in the know, the government is likely to consider as valid only the brand names which were approved first by the regulator. Other same or similar sounding and lookalike brands will not be allowed to be marketed. Drug makers will soon be asked to upload formulation details along with the brand names of their products on the government’s portal. This issue was recently discussed in the health ministry. “It has been brought to the notice that a large number of drugs are being sold in India with identical brand names treating entirely different conditions,” a person in the know told ET. “The consequences of confusion between these medications at the pharmacy can be serious for patients.” To address the issue of identical brand names in the market, the government has proposed that the database of all the products with brand names in the Sugam portal be made accessible to the public. India has been grappling with the issue of manufacturing and marketing of different drugs with the same brand name for long, another person in the know told ET. One such example include ‘Olvance’ a brand name for the antihypertensive drug olmesartan, and ‘Oleanz’, a brand of the antipsychotic drug olanzapine. Another is IMOX (amoxicillin tablets for humans) and INIMOX (a combination of amoxicillin and cloxacillin10 as an injection for veterinary use). In January, the Drugs Technical Advisory Board, India’s apex drug advisory body , deliberated on the issue of same brand name (including lookalike and soundalike ones) for different category of products and it suggested that to ensure patient safety, manufacturing and marketing of different drugs with the same brand name should not be allowed. After that, the director general of health services (DGHS) has written to the Controller General of Patents , Designs and Trade Marks, seeking increased surveillance and monitoring of trademarks associated with pharmaceutical products to identify instances of similarity or confusion. “It has come to our attention that various drugs, including those with soundalike and lookalike names, are being produced and distributed under identical or similar trademarks. The situation not only creates confusion among healthcare professionals and patients but also increases the likelihood of medication errors, adverse drug reactions and other serious health consequences,” the DGHS letter said. The letter sent in May was to ensure the integrity of pharmaceutical trademarks and protect public health by stricter implementation of trademark regulation, another person said. The DGHS has asked the trademarks office to prioritise the issue and take immediate steps to strengthen trademark regulations for medicines. The drugs consultative committee will deliberate and give its recommendations in the matter this month, a person in the know said. Source: Healthworld