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SC rejects plea against NEET-PG 2022

June 11,2024 The Supreme Court on Tuesday rejected a plea alleging discrepancies in the NEET-PG examination conducted in 2022 for admissions to post-graduate courses in various streams of medical sciences and seeking disclosure of answer keys and answer sheets. “These petitions are rendered infructuous due to the passage of time,” said a vacation bench comprising Justices Vikram Nath and Ahsanuddin Amanullah while dismissing a plea filed by a candidate named Pritish Kumar and others in 2022. The counsel for Kumar and others said the plea has not become infructuous as two out of the six petitioners would be taking up NEET-PG on June 23 this year. The National Eligibility-cum-Entrance Test-Post Graduate (NEET-PG) examination is conducted by the National Board of Examination (NBE) for admissions in various PG courses after the students complete MBBS, BDS and other equivalent courses. “The trouble is they (NBE) are not allowing us to access the answer keys, answer sheets, question papers (of NEET-PG 2022),” the lawyer said. The bench rejected the plea saying that it cannot keep it pending “unnecessarily”. Pritish Kumar and others had filed the plea alleging that there were mismatches in their NEET-PG 2022 scores and the NBE was not permitting re-evaluation. Source: Economic Times

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We, the children, must receive protection

June 07,2024 A recent investigation has brought to light a troubling issue within India’s prison system – a staggering number of wrongly incarcerated children are being held in adult prisons. A recent iProbono report, based on RTI responses, revealed that nearly 10,000 minors were wrongly locked up in adult prisons between Jan 2016 and Dec 2021. It is very likely that this number doesn’t reveal the entire picture because information was only sought from central and district jails in 28 states and two UTs, and only half of the prisons responded. This is scandalous for a nation that purportedly invests its future in its young. The Juvenile Justice (Care and Protection of Children) Act 2015 states that placing a child in an adult prison is unlawful. As per the Act, a child alleged to have committed an offence, or found guilty of an offence, is to be placed in an appropriate juvenile home – observation home, special home or a place of safety. Commenting on the JJ Act, the Supreme Court in 2005 had said, ‘The Act is not only a beneficent legislation, but also a remedial one. The Act aims to grant the care, protection, and rehabilitation of a juvenile vis-a-vis adult criminals.’ The first objective of the state is the promotion of the well-being of the juvenile, and the second is to bring about the principle of proportionality, by which proportionality of the reaction to the circumstances of both offender and offence, including the victim, should be safeguarded. The state has failed to implement the law on all counts. Affixing responsibility is critical, as is improving the juvenile corrections system by creating a network of observation homes, special homes and places of safety. Efforts to increase awareness of rights and access to legal aid will help protect rights of such hapless young Indians. Source: Economic Times

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Fundamental Right To Health Includes Customer’s Right To Be Made Aware Of Quality Of Products : Supreme Court

May 16,2024 The Supreme Court has declared that the the fundamental right to health encompasses the right of a consumer to be made aware of the quality of products being offered for sale by manufacturers, service providers, advertisers and advertising agencies. To protect this right, the Court directed that henceforth, before an advertisement is printed/aired/displayed, a Self declaration shall be submitted by the advertiser/advertising agency on the lines contemplated in Rule 7 of the Cable Television Networks Rules, 1994. The direction was passed by a bench comprising Justices Hima Kohli and Ahsanuddin Amanullah in the Patanjali case (Indian Medical Assocaition v. Union of India and others) on May 7. In the copy of the order uploaded today, the Court made certain pertinent observations regarding the customers’ rights. It may be recalled that the case was filed by the IMA seeking regulation of the misleading medical advertisements published by Patanjali Ayurved Ltd. During the course of the case, the Court initiated contempt proceedings against Patanjali Ayurved, its founders Baba Ramdev and Acharya Balkrishna. Advertisers and endorsers are equally responsible for issuing false and misleading advertisements In the order dated May 7, the Court commented on the responsibility of celebrities and influences who endorse products in advertisements. “We are of the firm view that advertisers/advertising agencies and endorsers are equally responsible for issuing false and misleading advertisements. Such endorsemehat are routinely made by public figures, influencers, celebrities etc. go a long way in promoting a product. It is imperative for them to act with a sense of responsibility when endorsing any product and take responsibility for the same, as reflected in Guideline No.8 of the Guidelines, 2022 that relates to advertisements that address/target or use children for various purposes and Guideline No.12 that lays down the duties of manufacturers, service providers, advertisers and advertising agencies to ensure that the trust of the consumer is not abused or exploited due to sheer lack of knowledge or inexperience. Guideline No.13 requires a due diligence to be undertaken for endorsement of advertisements and requires a person who endorses a product to have adequate information about, or experience with a specific good, product or service that is proposed to be endorsed and ensure that it must not be deceptive.” The Court also noted that there is no robust mechanism available for the customer to lodge complaints for violation of Guidelines for Prevention of Misleading Advertisements and Endorsements of Misleading Advertisements, 2022 framed by the Ministry of Consumer Affairs. “In view of the above and in the absence of any robust mechanism enacted in law to ensure that the obligations cast on the advertiser to adhere to stipulations in the Guidelines, 2022 in letter and spirit, it is deemed appropriate to invoke the powers vested in this Court under Article 32 of the Constitution of India for the enforcement of the fundamental right to health that encompasses the right of a consumer to be made aware of the quality of products being offered for sale by manufacturers, service providers, advertisers and advertising agencies. The Court directed that the Self-declaration shall be uploaded by the advertiser/advertising agency on the Broadcast Sewa Portal run under the aegis of the Ministry of Information and Broadcasting. As for the advertisements in the Press/Print Media/Internet, the Ministry is directed to create a dedicated portal within four weeks from May 7. Immediately on the portal being activated, the advertisers shall upload a Self-declaration before any advertisement is issued in the Press/Print Media/Internet. Proof of uploading the Self-declaration shall be made available by the advertisers to the concerned broadcaster/printer/publisher/T.V. Channel/electronic media, as the case may be, for the records. No advertisements shall be permitted to be run on the relevant channels and/or in the print media/internet without uploading the self- declaration as directed above. The above directions shall be treated as the law declared by this Court under Article 141 of the Constitution of India. Source: Livelaw

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FSSAI alerts traders to ensure compliance with prohibition of calcium carbide in fruit ripening

May 19,2024 New Delhi: The Food Safety and Standards Authority of India (FSSAI) has alerted traders, fruits handlers and Food Business Operators (FBOs) who are operating ripening chambers to strictly ensure compliance with the prohibition on Calcium Carbide for artificial ripening of fruits, particularly during the mango season. FSSAI is also advising Food Safety Departments of States/UTs to remain vigilant and take serious action and deal stringently against person(s) indulging in such unlawful practices as per the provisions of FSS Act, 2006 and Rules/Regulations made thereunder, the Ministry of Family and Health Welfare informed in a press release. Calcium carbide, commonly used for ripening fruits like mangoes, releases acetylene gas which contains harmful traces of arsenic and phosphorus. These substances, also known as ‘Masala’, can cause serious health issues such as dizziness, frequent thirst, irritation, weakness, difficulty in swallowing, vomiting and skin ulcers, etc. Additionally, acetylene gas is equally hazardous to those handling it. There are chances that calcium carbide may come in direct contact with fruits during application and leave residues of arsenic and phosphorus on fruits, the release stated. Due to these dangers, the use of calcium carbide for ripening fruits has been banned under Regulation 2.3.5 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. This regulation explicitly states, “No person shall sell or offer or expose for sale or have in his premises for the purpose of sale under any description, fruits which have been artificially ripened by use of acetylene gas, commonly known as carbide gas.”Considering the issue of rampant use of banned calcium carbide, FSSAI has permitted the use of ethylene gas as a safer alternative for fruit ripening in India. Ethylene gas can be used at concentrations up to 100 ppm (100 ml/L), depending upon the crop, variety and maturity. Ethylene, a naturally occurring hormone in fruits, regulates the ripening process by initiating and controlling a series of chemical and biochemical activities. The treatment of unripe fruits with ethylene gas triggers the natural ripening process until the fruit itself starts producing ethylene in substantial quantities. Further, the Central Insecticides Board and Registration Committee (CIB & RC) has approved Ethephon 39 per cent SL for the uniform ripening of mangoes and other fruits. The Ministry emphasised that FSSAI has published a comprehensive guidance document titled “Artificial Ripening of Fruits – Ethylene gas a safe fruit ripener” suggesting the Food Business Operators to follow the procedure for artificial ripening of fruits. This document outlines a Standard Operating Procedure (SOP) incorporating all aspects of artificial ripening of fruits by ethylene gas viz. Restrictions, Requirements for Ethylene Ripening System/Chamber, handling conditions, Sources of Ethylene Gas, Protocol for application of Ethylene gas from various sources, post treatment operations, safety guidelines etc. “In case any use of Calcium Carbide or any wrong practice of using ripening agents for artificial ripening of fruits is noticed by the consumers, the same may be brought to the notice of concerned State Commissioners of Food Safety for taking action against such violators,” the release added. Source: Healthworld

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Label Padhega India: A key step to build consumer awareness

May 24,2024 Mumbai: The ‘Label Padhega India’ campaign, an important step in building domestic consumer activism and fostering awareness, underscores the inherent issues related to product labelling locally. Still, products aimed at more sensitive consumer segments, such as children, may undergo greater manufacturer scrutiny. “Label Padhega India campaign has the potential to become the second largest consumer campaign after the ‘Jaago Grahak Jaago’ campaign by the Indian government,” said Harish Bijoor, brand strategy specialist. “However, for that to happen, the digital marketing has to be strong. Companies will not pay heed to the campaign until it gains larger traction and manages to yield a change in consumer behaviour. The onus on the influencers is to garner traction for the campaign by advertising it on a larger scale across media.” Product labelling in India faces several issues – ranging from non-compliance with the regulations, language barriers, misinformation and misleading claims, inconsistent labelling standards, illegible labels, lack of transparency, inadequate enforcement of the labelling regulations and imported goods not meeting the Indian labelling standards. “The campaign is an effective step in the right direction with its timing being right – coming days after the Supreme Court strictures on Patanjali and its founders for misleading advertisements,” said business strategist and FMCG industry expert Lloyd Mathias. “However, there are issues with product labelling in India.” Consumers, globally, do not generally read the product labels minutely to find out about the ingredients used. Hence, the use of pictorial labels has become more widespread. Countries such as Chile, Mexico, Peru, Brazil and Israel have implemented the use of pictorial warnings on food labels. For instance, Chile uses black octagonal signs to indicate high levels of sugar, sodium, calories and saturated fats. In India, green dots on food products indicate that the product is vegetarian. But, as Mathias said, the intended outcome from product labelling faces a question mark due to inherent issues. “First, to what extent companies are truthful about their labels. Second, how stringent is the law enforcement on product labelling by the FSSAI. Third, local and small brands selling snacks or fast foods go past the FSSAI regulations,” Mathias said. “However, the campaign is important in drawing public attention toward nutritional information about the product and is likely to appeal to young, urban consumers. It emphasises that the onus is on the consumer to make an informed buying decision. The jury is out on the potential impact of the campaign on buying behaviour. “I don’t think that the campaign will make a significant difference in terms of consumer buying patterns, since most consumers are either making a conscious choice or don’t have alternative options to choose from,” said Sachin Bobade, VP – research, Dolat Capital. To be sure, product labelling is a small aspect of consumer awareness. “Displaying labels as part of the advertising campaign proves to be more effective than simply product labelling since only around 0.2% of the consumers in India read packaging on the product,” Bijoor said. “The law currently doesn’t mandate showing labels in the product advertising. But a display of the product label in a digital ad is effective in communicating the contents to the consumer.” The Label Padhega India campaign nevertheless is likely to prompt companies to re-jig their product portfolio. According to Mathias, the companies are very sensitive about what is said about them. “Once the campaign starts garnering attention, a lot of companies will look at ways in which their labelling can become better,” he said. “The campaign may prompt companies to relook at their product portfolio – especially the ones targeted for kids,” said Bobade. “Companies will have to change the contents or proportion of sugar, salt or fats in the products – that may lead to changes in taste and increase in prices. But their concern would be whether consumers continue to prefer the products with changed taste and higher prices,” he said. “A sizable public chatter building up shall make the regulator wake up. The regulator can issue specifications related to the size, font and other details of the label, guidelines for companies to follow especially when they are selling the same product in different parts of the world and improve the enforcement of the laws at the last mile,” Mathias added. Source: Economic Times

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No single theme to drive market; volatility to continue: Milind Karmarkar

June 10,2024 “I am not saying that the market will go up five times, but I am seeing the repeat of that. So, we are seeing, as you said, huge volatility, not the kind which we saw earlier, but still a huge volatility,” says Milind Karmarkar, Dalal & Broacha Portfolio Manager. So, actually, again, as always, I go back in history. So, in fact, 2002 to 2008, that period was one of the best periods to be in the markets because you saw the best, you saw the worst. You saw what happens after a coalition comes in power. You see what happens when a liberal party like Congress is supported by communists, the market goes down 20% and after that the market goes up five times. You have seen that happen. I think we are seeing a repeat of that. I am not saying that the market will go up five times, but I am seeing the repeat of that. So, we are seeing, as you said, huge volatility, not the kind which we saw earlier, but still a huge volatility. And now we have a government which is a coalition government all said and done, though BJP has a significant number of seats, but it is a coalition government and there will be coalition politics will come into play. So, my belief is that whenever a coalition is at the centre, then you see a decent growth. The clear focus is economics. The clear focus is to do better for the masses and that is what drives the markets, that is what drives the economy as well. My view is that, frankly, now the market is far better discovered than what it was in 2003-04. There are so many analysts, there are so many funds, and everyone is researching companies. So, according to me, market is fairly discovered market. There may not be a single theme which will drive the market. The only mega trend which I see and I have been talking about it earlier also is consumption and rising per capita income. So, whichever industries benefit out of that will continue to do well. Within that, of course, there are smaller trends which are also there, like you said, whether it is railways, whether it is power. But again, there is a slight difference here. What will happen probably is that the PE expansion will not happen going forward. You will get the returns which earnings will give you. I do not see it immediately. Five years down the line, I do not know. But immediately, at least it is unlikely that the PEs will contract, especially in themes like railways, power and these, because there is a defined growth path there for next four-five years. Source: Economic Times

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Drugs with labels of Animal Husbandry Veterinary Sciences panic patients

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

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CDSCO declares 50 samples tested in April as NSQs, majority states fail to submit data

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

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56% of India’s disease burden due to unhealthy diet: ICMR report

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

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Delhi HC dismisses PIL to mandate all medical professionals to specify possible risks of prescribed drugs

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

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