August 29,2024 New Delhi: The government will shortly notify a revised version of good manufacturing practices (GMP), at par with the World Health Organization (WHO) standards, for small pharmaceutical companies with an annual turnover of less than ₹250 crore. Companies with an annual revenue of up to ₹250 crore fall under the micro, small, and medium enterprises (MSMEs) category. As part of the government’s guidelines, which were announced in July 2023 and notified in December, drugmakers with an annual turnover of more than ₹250 crore were to compulsorily follow GMP within six months, while those with a turnover of less than ₹250 crore were supposed to do so over a 12-month period. “Already GMP is applicable for bigger companies that have annual turnover of ₹250 crore or above. The government notified the GMP guidelines last year on 28 December. However, smaller firms were given time for one year to create an enabling environment to comply with GMP rules. A revised version of the GMP at par with WHO standards is in the works and will shortly be notified to be effective from December onwards,” a government official aware of the matter said. The government is also doing risk-based assessment of these bigger companies to check whether GMP is being followed, and suitable action is being taken against errant companies, the official said on the condition of anonymity. Queries sent to a health ministry spokesperson remained unanswered till press time. Earlier this month, Union health minister J.P. Nadda said in parliament that more than 300 measures, including show-cause notices, production-halt order, suspension, cancellation of licences /product licences etc., were ordered based on the risk-based assessment of the drug firms by the state licensing authorities and Central Drugs Standard Control Organisation (CDSCO) under the provisions of the Drugs Rules 1945. Last year, the Centre revised Schedule M of the Drugs and Cosmetics Rules, 1945, which prescribes good manufacturing practices, or GMP standards for drug firms. GMP is a set of mandatory guidelines for pharmaceutical companies to maintain the quality of products by way of controlling the quality of raw materials, methods, machines, processes, personnel, facility and environment, among other things, used in the manufacture of pharmaceutical items. This revision of Schedule M was done in view of allegations of contaminated cough syrups manufactured by Indian firms that were allegedly linked to deaths of children in developing countries, including 66 in Gambia and 68 in Uzbekistan in 2022. The GMP compliance would secure India’s image as the pharmacy of the world and bring the country’s drug manufacturing capability at par with global standards, especially those issued by the WHO. Moreover, this would ensure the production of globally-acceptable quality of drugs. Mint recently reported about the Drugs Controller General of India (DCGI) considering issuing and renewing licences only to those pharmaceutical firms that can prove they follow GMP. There are around 10,500 drug manufacturing units in India, of which around 8,500 fall under the MSME category. “We are educating our member companies on the GMP guidelines and how to work on it. Workshops are being created on the same. However, one year’s time was a very a little period to do such a mammoth task. It is easier to start a new factory than to upgrade the existing one and this activity consumes a lot of time. We have submitted our request to the Union health minister and Drugs Controller General of India to extend our deadline,” said Harish Jain, president, Federation of Organizations of Pharmaceutical Entrepreneurs (FOPE), an association of MSME drug firms. Source: Livemint

August 27,2024 New Delhi: Union Minister Prataprao Jadhav on Monday said special medical stores will be opened in every tehsil of the country to ensure adequate availability of AYUSH medicines. The Union AYUSH Minister also said the government is mulling on ways to ensure Ayurvedic medicines based on traditional knowledge get due recognition. “Only a few AYUSH medicines are available in common medical stores, due to which patients and doctors prescribing these medicines face problems. The government wants to ensure AYUSH drugs come into the market in abundance after research. These medicines should be available everywhere. For this, we are trying to open at least one special medical store of AYUSH medicines in every tehsil of the country,” he said. AYUSH hospitals are also being opened at the tehsil level, said the minister, who also visited medical institutes in Indore, Dewas and Ujjain and reviewed facilities there. Source: Healthworld

August 26,2024 As the globe faces a rise in antibiotic-resistant bacteria – making traditional antibiotics ineffective – specific viruses could offer a solution. Viruses called bacterio phages, or phages, target bacteria but can’t infect humans or other higher organisms. Phages inject their DNA into the bacterial cell, multiply to large numbers using the resources of the host, and then burst out to infect more bacteria in the vicinity. Essentially, they are a naturally occurring, self-replicating and specific antibiotic. Discovered more than 100 years ago, their use against bacteria was largely sidelined in favour of antibiotics. Our new research looked at one particular protein used by phages to bypass the natural defences of bacteria. We found this protein has an essential control function by binding to DNA and RNA. This increased understanding is an important step towards using phages against bacterial pathogens in human health or agriculture. Bacterial defence systems There are hurdles to using phages to target bacteria. Much like our bodies have immune mechanisms to fight off viruses, bacteria have also evolved defences against phage infections. One such defence are “clustered regularly interspaced short palindromic repeats”, or CRISPR, now better known for its applications in medicine and biotechnology. CRISPR systems in general act as “molecular scissors” by cutting DNA into pieces, be it in a lab-based setting or, in nature, inside a bacterium to destroy a phage. Imagine wanting to use a phage against an antibiotic-resistant bacterial infection. The only thing standing in the way of that phage killing the bacteria and eradicating the infection might be the bacterium’s CRISPR defence which renders the phages useless as an antimicrobial. That’s where knowing as much as possible about phage counter-defences becomes important. We are investigating so-called anti-CRISPRs: proteins or other molecules that phages use to inhibit CRISPR. A bacterium that has CRISPR might be able to stop a phage from infecting. But if the phage has the right anti-CRISPR, it can neutralise this defence and kill the bacterium regardless. The importance of anti-CRISPRs Our recent research focused on how an anti-CRISPR response is controlled. When faced with a powerful CRISPR defence, phages want to automatically produce large amounts of anti-CRISPR to increase the chance of inhibiting CRISPR immunity. But excessive production of anti-CRISPR prevents the replication of the phage and is ultimately toxic. This is why control is important. To achieve this control, phages have another protein in their toolbox: an anti-CRISPR-associated (or Aca) protein that frequently occurs alongside the anti-CRISPRs themselves. Aca proteins act as regulators of the phage’s counter-defence. They make sure the initial burst of anti-CRISPR production that inactivates CRISPR is then rapidly dampened to low levels. That way, the phage can allocate energy to where it is most needed: its replication and, eventually, release from the cell. We found this regulation occurs at multiple levels. For any protein to be produced, the gene sequence in the DNA first needs to be transcribed into a messenger-RNA. This is then decoded, or translated, into a protein. Many regulatory proteins function by inhibiting the first step (transcription into messenger-RNA), some others inhibit the second (translation into protein). Either way, the regulator often acts as a “road block” of sorts, binding to DNA or RNA. Intriguingly and unexpectedly, the Aca protein we investigated does both – even though its structure would suggest it is merely a transcriptional regulator (a protein that regulates the conversion of DNA to RNA), very similar to ones that have been investigated for decades. We also examined why this extra-tight control at two levels is necessary. Again, it seems to be all about the dosage of the anti-CRISPRs, especially as the phage replicates its DNA in the bacterial cell. This replication will invariably lead to the production of messenger-RNAs even in the presence of transcriptional control. Source: Healthworld

August 26,2024 New Delhi: An affordable tuberculosis testing technology that can detect the disease using a patient’s sputum for just Rs 35 has been developed by apex medical research body ICMR’s regional centre in Assam’s Dibrugarh. The ‘A CRISPR case-based TB detection system ‘ is light, portable and involves three steps of testing. Over 1,500 samples can be tested in one single run in around two-and-half hours, ICMR sources said. Conventional diagnostic techniques for TB commonly rely on culture, which requires 42 days to confirm as TB negative, microscopy, and nucleic acid-based methods. These are also time-consuming and may require sophisticated equipment. An official said, “Tuberculosis (TB) remains a global health challenge, necessitating the development of accurate and rapid diagnostic tools for effective disease management. Current diagnostic methods often exhibit limitations in terms of sensitivity, specificity, speed and cost, emphasising the need for innovative approaches”. Additionally, some molecular diagnostic methods, while offering improved sensitivity, may lack the desired specificity or face challenges associated with cost and ease of handling. “Considering these problems, the CRISPR-Cas12a-based molecular diagnostic system ‘GlowTBPCRKit’ coupled with an amplification step (using thermal cycler) and the ‘ RapidGlow device ‘ provides a promising solution,” the official said. The Indian Council of Medical Research (ICMR) has now invited Expression of Interest (EoI) from eligible organisations, companies, manufacturers for undertaking ‘Transfer of Technology’ for commercialisation of the ‘A CRISPR case-based TB detection system’ for the detection of Mycobacterium tuberculosis. The ICMR-RMRCNE institute will provide expert guidance and technical support for the production of ‘A CRISPR Cas based TB detection system’ in all phases. Such technical oversight by the institute would accelerate the development of the product and its commercialisation. The ICMR would also provide technical support through its team of experienced scientists in study, planning, product development, development of study protocol, results or data analysis, outcome assessment, safety and efficacy assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company. The apex health research body through its institutes would provide support and facilitation to conduct the research and development or clinical study of new technology or product in India through its affiliates or institutes, in collaboration with the company and institutions in a professional and mutually agreed upon manner and timelines. Source: Healthworld

August 24,2024 The Central Drugs Standard Control Organisation (CDSCO) has released a list of 70 drug samples declared as Not of Standard Quality (NSQ), with samples of drugs labelled as manufactured by some of the major companies failing the quality test. The State drug regulators have reported 13 NSQs to the CDSCO in the prescribed format, while CDSCO released the list of 57 NSQs during the month. During July also a large number of States and Union Territories did not submit any data related to NSQ alert to the CDSCO, it reported. The list of drugs failed the quality test by the CDSCO and Central Laboratories during the month of July include samples of budesonide nebuliser suspension BP (Budecort Respules) and tamsulosin and dutasteride tablets (Urimax-D) labelled as manufactured by Cipla Ltd, amoxycillin and potassium clavulanate tablets IP (Pressclav625) labelled as manufactured by Aurobindo Pharma, and carboplatin USP labelled as manufactured by Hetero Labs. Samples of compound sodium lactate injection (Ringers Lactate Solution for Injection) labelled as manufactured by public sector enterprise Hindustan Antibiotics Ltd, and ofloxacin and ornidazole tablets and paracetamol tablets IP 650 mg labelled as manufactured by Karnataka Antibiotics and Pharmaceuticals Ltd were also declared as NSQs by the CDSCO. Even though the labels claim major companies as manufacturers of these failed products, in the past some of these companies have informed the regulator that the samples were not manufactured by them and are spurious drugs. The list of drug samples declared as NSQ by the state laboratories include new improved gentle daily care natural protein shampoo labelled as manufactured by Himalaya Wellness Company, and several drugs supplied by Kerala Medical Services Corporation, among others. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of July, 2024 as per DCG(I) Circular dated February 9, 2024, said the CDSCO. The Union Territories which failed to submit the data include Delhi, Pondicherry, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep. Besides, NSQ data was not received as per the format in Excel sheet prescribed by the DCGI’s circular from the State Drugs Licensing Authorities of Karnataka and Jharkhand for the month of July, 2024. It may be noted that the CDSCO has changed its data releasing format related to NSQs for the public, from the month of May, and started publishing the names of States and Union Territories which are not submitting the monthly data on NSQ to the Central drug regulator in the stipulated format within the time limit. Interestingly, the CDSCO also stopped publishing the drugs which are suspected or reported as spurious, while the data was part of its earlier data format. 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 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. During the meeting, 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. Source: Pharmabiz

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, “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. Amid a sea of skincare products brimming with harsh actives and exfoliating acids, I found something that embraces a different path. The face serum by Molecule53 boasts a peptide-first approach. Unlike aggressive acids—found in almost all serums today—peptides work harmoniously with your skin, encouraging natural renewal processes without causing undue stress or irritation. The packaging is simple and non-fancy. So is the serum—a colourless, odourless solution. It is straightforward and means business. I used it for a month and was impressed with the result. There were fewer fine lines and the skin appeared a tad tighter. It’s one of the best products I have tried of late which successfully address anti-ageing. Use it at bedtime just before applying an under-eye gel and hydrating moisturiser. During the daytime, wear it underneath the sunscreen. The non-sticky formula keeps the skin clear of breakouts and acne. Brownie points for being vegan! Source: Indian Express