August 2024

August 13,2024 In less than a week since the Drugs Controller General of India (DCGI) has given permission to pharma companies to launch certain types of drugs without local clinical trials, the economic think tank GTRI (Global Trade Research Initiative) has opposed the decision. GTRI has said that the decision is going to adversely impact the patients in India and could hurt the domestic pharma industry. “By overlooking India’s unique genetic diversity, the waiver could lead to unexpected safety and effectiveness issues. Also, it might increase competition from multinational corporations making it harder for local pharma companies and contract research organisations (CROs) to grow,” GTRI said in a statement. As per the think tank, the genetic make-up of Indians are different from the US and EU who have diverse population, and therefore, it’s essential to do local trials to ensure that new drugs are both safe and effective for Indian patients. The DGCI has exempted the local clinical trials across five categories of new drugs, including drugs for rare diseases, gene and cell therapies, pandemic-related treatments, and those with significant therapeutic advances. GTRI said that many of these drugs are developed quickly, and are experimental. “Some companies get approval abroad but choose not to sell these drugs there due to concerns about patent protection and potential compensation if something goes wrong. Instead, they focus on countries with weaker regulations like India. We must exercise caution as many such drugs can lead to serious and sometimes dangerous outcomes,” GTRI said. Meanwhile, pharma association said that even though the companies are not required to do phase 3 trials now, they will still have to conduct post-marketing surveillance studies across thousands of patients. “While phase 3 trials are no longer required for certain new drugs, the companies will still have to conduct phase 4 studies which happens after the product launches,” said Anil Matai, director general, Organisation of Pharmaceutical Producers of India (OPPI). Further, GTRI said that the waiver could affect local firms and CROs at the cost of MNC pharma companies.  “The reduction in the number of clinical trials could hinder the growth of over 250 local CROs. MNCs have argued that clinical trials in India were too expensive even though they cost much less than in the US. This (waiver) benefits MNCs by reducing costs and time, allowing them to launch new drugs faster. They also avoid the risk of compensation and liability if something goes wrong during trials,” said GTRI. Source: Financial Express

July 30,2024 Five out of 12 Centres of Excellence (COEs) formed to treat patients suffering from rare diseases have utilised less than 35 per cent of the funds allotted to them by the Centre over the last three years, according to patient advocacy groups and data from a reply given in Parliament.   According to data accessed by Business Standard, the maximum fund utilisation was seen at Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata at 93.65 per cent. The next in the chart was King Edward Medical Hospital, Mumbai at 93.55 per cent. Hyderabad-based Centre for DNA Fingerprinting & Diagnostics with Nizam’s Institute of Medical Sciences stands last in the list with only 4.53 per cent funds utilisation. Followed by Delhi’s Maulana Azad Medical College at 17.62 per cent. According to a reply given by the health ministry in Parliament, as of February this year these centres have utilised only 48% of around Rs 109 crore disbursed in the last three years. COEs are institutions identified by the central government to actively treat patients suffering from rare diseases. Currently, 12 such centres have a quota of 2,420 rare disease patients from six categories across three groups.  “While the government has set up CoEs to treat patients with rare diseases, patients with Group 3a conditions are still experiencing inordinate delay in procedural formalities across these centres,” a member associated with an advocacy group for patients with Group 3a conditions said.   According to the rare disease policy enacted in 2021, Group 3a includes conditions such as Lysosomal Storage Disorders (LSD’s) for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost, and lifelong therapy.  “There are currently around 454 eligible rare disease patients with LSD’s such as Pompe disease, Fabry disease, Mucopolysaccharidosis (MPS) type I and type II in India, to be put on immediate life-saving therapy as per the National Policy for Rare Diseases 2021,” the member added.  Source: Business Standard

August 13,2024 The Central Drugs Standard Control Organization (CDSCO) has directed makers of sterile equipment to comply with Schedule M of the Drugs and Cosmetic Rule, which mandates companies to follow Good Manufacturing Practices (GMP) at par with the World Health Organization (WHO) standards. Till now, GMP has been compulsory for only drug makers but compliance is regarded as equally important for sterile product and vaccines makers. The development assumes significance given the growing size of the Indian sterile equipment market.  “The revised GMP notification which was published last December is generally for all types of pharmaceutical items. It prescribes general requirements that need to be followed by all the pharmaceutical firms. The notification clearly specifies the requirements for each type of product such as sterile products, biologicals, ophthalmic solutions and other injectables etc.,” said an official. “In addition to the general requirements, WHO publishes their guidelines from time to time for various products. Companies have been told to do the self-assessment, take necessary steps to fill the gaps and strengthen GMP compliance as per WHO standards,” said the official mentioned above. These products include surgical equipment, forceps, biopsy equipment, eye equipment including soft contact lenses, eye solutions, arthroscopes, and laparoscopes and injectables which directly goes into the bloodstream of the patient. Good Manufacturing Practices, or GMP, as mandated by the WHO, prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, and the environment. The government, last year in December, had amended or revised the Schedule M of the Drugs and Cosmetics Rules, 1945 to upgrade, tighten and make GMP norms mandatory, especially for micro, small and medium enterprises (MSMEs). As part of the government’s guidelines, which were announced in July 2023 and notified in December 2023, pharma companies with annual turnovers of over ₹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. Compliance of GMP guidelines was made stronger to ensure the quality standards of drugs being manufactured in India after the Central government’s risk-based inspection of pharmaceutical firms found serious lapses at the manufacturing site such as infrastructural deficiencies, poor documentation, under-skilled employees, absence of testing of raw material etc. This was done in the backdrop of Indian cough syrups causing the deaths of children in Gambia and Uzbekistan. “This is with reference to revision of schedule M and WHO good manufacturing practices for sterile pharmaceutical products, which are published by WHO from time to time. In this regard, it is requested that all manufacturers should take necessary steps for compliance with respect to various requirements as per the guidelines after due gap analysis,” said DCGI in a communication on 7 August to all sterile and vaccine manufacturers. Aniket Dani, Director-Research, CRISIL Market Intelligence & Analytics said, “As per the latest available data, the domestic vaccines market size stood at about Rs. 1,700 crore for fiscal year 2024. This segment contributed about 1% of the overall domestic formulations market.” Rajiv Nath, Forum Coordinator of AiMeD (Association of Indian Medical Devices Industry) said that the market for medical sterile medical devices may be over $ 4-5 billion. Meanwhile, the government is continuously conducting risk-based assessment of these pharmaceutical companies Health minister J.P. Nadda recently stated in Parliament that in the last one year the government had conducted risk-based inspections of 400 pharma companies to check if they are following GMP rules. As a part of the inspection, more than 300 show cause notices, stop production order, suspension, cancellation of licences have been issued. Source: Drugs Control

August 12,2024 The Drugs Controller General of India (DCGI), the country’s top drug regulator, has framed standard operating procedure and guidelines to ensure product traceability throughout the supply chain, as the menace of fake and spurious medicines grows. The DCGI has circulated this good-distribution practice as traceability is a big challenge due to a lack of proper documentation throughout the distribution channel. The development assumes significance as the Indian pharmaceutical industry has come under global glare following allegations that spurious cough syrups from the country were linked to children’s deaths in Gambia, Cameroon, and Uzbekistan. In the recent DCGI’s drugs consultative committee meeting held in June, it was decided to incorporate good distribution practice as a Schedule in the Drugs and Cosmetic Rule, 1945. It was discussed that due to the non-mandatory nature of guidelines, the maintenance of storage conditions of drugs during the transit till wholesale and retail level was not ensured by the manufacturers. These draft guidelines on good distribution practice have been framed at par with World Health Organization standards and stakeholders can send in their comments and suggestions over the next 30 days, before the rules are finalized. Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945 specify the conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute the drugs across the country. The draft guidelines said that individuals such as manufacturers and wholesalers, brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees are generally responsible for the handling, storage and distribution of pharma products. Therefore, to maintain the original quality of pharmaceutical products, every party involved, such as in the distribution chain, must comply with the standards of good distribution practice. “Substandard and spurious products are a significant threat to public health and safety. This guideline is meant for those involved in the supply chain of medical items and their active role to protect the pharmaceutical supply chain against the penetration of spurious/substandard pharmaceutical products,” said a state drug controller, requesting not to be named. “The nature of the risks involved is similar to that encountered in the manufacturing environment, for instance, mix-ups, adulteration, contamination, cross-contamination, spurious. The involvement of unauthorized people in the distribution and sale of pharmaceutical products is a particular concern,” the official cited above said, adding that these guidelines can be used as a tool to curb the distribution of substandard and spurious products. The guidelines underlined the procedures to ensure a safe, transparent and secure distribution system which includes product traceability throughout the supply chain. It said that there shall be procedures in place to ensure document traceability of products received and distributed, to facilitate product recall, the guidelines said. All individuals involved in supply-chain of drugs must ensure that all pharmaceutical products have documentation that can be used to trace the products throughout distribution channels from the manufacturer to importer to the entity responsible for selling or supplying the product to the patient or his or her agent. Records including expiry dates and batch numbers shall be part of a secure distribution documentation enabling traceability. It shall be ensured that records of dispatch contain enough information to enable traceability of the pharmaceutical product. ‘Such records shall facilitate the recall of a batch of a product, if necessary, as well as the investigation of spurious or potentially spurious pharmaceutical products; the assigned batch number and expiry date of pharmaceutical products shall be recorded at the point of receipt to facilitate traceability,” it said. The guidelines also state that senior management of each entity should be responsible for ensuring that an effective quality system is established, resourced, implemented and maintained, and periodic meetings held to review the work. Source: Drugs Control

August 04,2024 Ever since childhood, one thing we have all been taught about is the detriments of excessive consumption of sugar. From candies and chocolates to cookies and flavoured beverages – the consistent efforts to control sugar intake have existed for as long as we can remember. However, the consumption of salt – the most widely used ingredient across the world – is another story. While a majority of us are aware of the pros and cons of excessive sodium intake, there is a lack of a consistent effort to address and implement it in our daily lives. Several studies have reported that excessive consumption of sodium leads to an array of detrimental health issues, from high body mass index (BMI) and obesity, to hypertension, cardiovascular diseases, and high blood pressure, alongside increased chances of heart diseases and stroke– all of which could massively impact the quality of life, thereby warranting attention towards stricter measures to lower sodium intake – right from childhood. While the World Health Organisation (WHO) recommends an intake of 5g salt/day, the average salt consumption in India stands at around 11g/day – which is over double the recommended intake. Although the recent guidelines updated by the Indian Council of Medical Research (ICMR) particularly mention ‘restrict salt intake’, its implementation across all walks of life remains rather doubtful without adequate intervention – particularly at an individual level. That being said, it is imperative to ensure that robust efforts are in place to maximise the implementation of such guidelines, especially among children and the youth, who are at the forefront of a healthier future. As much as India’s diversity is celebrated both globally and domestically, the diversity represented through the myriad cuisines India offers is one of the greatest challenges concerning their nutritional value/consumption. Research indicates that the three major sources of sodium in India are homecooked meals (contributing to 80 per cent of our dietary sodium), followed by street foods/food prepared in restaurants and packaged foods. Owing to the varied preparations of meals across cuisines, sodium intake also varies massively – in Assam, Kashmir, and Ladakh, for instance, salt is often added to their teas, making up for significant consumption of their sodium intake. The recent Household Consumption Expenditure Survey (HCES) released by the Ministry of Statistics and Programme Implementation (MoSPI), suggests that Indians residing in urban regions have spent more on beverages and processed food than on cereals since 2011-12, while in rural India, expenditure on processed foods and beverages have gone up from nearly 8 per cent in 2011-12 to nearly 10 per cent in 2022-23, despite an overall drop in food spending relative to monthly consumption expenditure. Owing to the affordability and accessibility of such packaged/processed foods across the country, dietary salt intake among Indians continues to reach new heights. While the ingredient is a predominant agent in increasing blood pressure and other cardiovascular diseases in adults, the origins often begin in childhood, thereby further increasing the urgency to deploy effective measures to raise awareness regarding lower salt intake. While fundamental nutrition schemes such as the Universal Salt Iodization Program (providing fortified salt – with both iodine and iron to address anaemia), the Mid-Day Meal scheme, and the Public Distribution System have made significant strides in ensuring adequate nutritional intake among Indians (specifically children), a multifaceted approach is crucial to effectively alter behavioural patterns and encourage healthy dietary habits. Currently, while we have data on the percentage of the population that uses iodized salt within India (over 94 per cent of the population uses iodized salt, as per NFHS 5), a central comprehensive database is paramount to facilitate the process of formalising effective strategies, generated basis the evidence on dietary salt intake, knowledge, and attitude. At the ground level, mass media campaigns providing strategies to reduce the use of salt in homecooked meals and raise general awareness about the adequate consumption of sodium may result in substantial changes in attitudes and behaviours among citizens – particularly those residing in Tier 2 and Tier 3 cities and rural areas. Additionally, research indicates that an increased potassium intake substantially reduces blood pressure in adults, while in children, increasing the consumption of potassium helps in reducing blood pressure to a certain extent. Hence, community engagement programmes are vital to not only educate but also encourage communities and families to reduce sodium intake while increasing the consumption of potassium-rich foods such as beans, peas, nuts, leafy vegetables, and fruits like bananas, papayas, and dates could alleviate the incidence of high blood pressure and coronary heart diseases, and cardiovascular diseases. Source: Healthworld

August 12,2024 New Delhi: The dengue vaccine Qdenga, pre-approved by the World Health Organization in May, has shown more than 50 per cent efficacy in reducing the number of cases, with lasting effects and a good safety profile, according to a review of 19 studies. The “first comprehensive global” review, covering more than 20,000 participants, found that upon receiving the two-dose vaccine, over 90 per cent of adults and children elicited an immune response against all four variants (serotypes) of the dengue-causing DENV virus . Of the 19 studies analysed, 13 contained data from Asian and South American locations where the disease is endemic. “Given the results in terms of safety, immunogenicity, and efficacy, the administration of two doses can undoubtedly be a key tool for dengue prevention ,” said Maria Elena Flacco from the University of Ferrara, Italy, and the lead author of the study published in the journal Vaccines. Developed by the Japan-based Takeda Pharmaceutical Industries Limited, the Qdenga vaccine — also called TAK-003 — is a live-attenuated vaccine, containing weakened versions of the four serotypes of the DENV virus. “TAK-003 showed an excellent safety profile, and the immunogenicity after two doses against the four DENV serotypes was higher than 90 per cent among both adults and children/adolescents who were either seronegative or seropositive at baseline,” the authors wrote. While seropositive indicates a prior dengue infection or exposure to DENV virus, seronegative indicates none of these. The authors also found that among those receiving a single vaccine dose, more than 70 per cent of adults and over 90 per cent of children and adolescents developed antibodies against the viral infection. “One of the included studies, with a very large sample, had a relatively long follow-up (4.5 years) and provided robust evidence of the long-term safety (and immunogenicity) of TAK-003,” the authors wrote. In February, Takeda and Biological E Limited, Hyderabad, announced a strategic partnership to accelerate access to the Qdenga vaccine. It is not yet approved for use in India. By ramping up its manufacturing capacity to up to 50 million doses a year, Biological E will help accelerate Takeda’s efforts to produce 100 million doses a year within the decade, according to the partnership. While the Qdenga vaccine has shown promising results, a comprehensive estimate of its effectiveness and safety was not available, the study’s authors said. The dengue-causing DENV virus spreads to humans from the bite of infected female Aedes aegypti mosquitoes (vector). Symptoms of dengue can include high fever, severe headache, muscle and joint pain, and rashes. In severe cases, the disease can be fatal. Tropical and sub-tropical climates are known to favour transmission of the vector-borne disease. About half the world’s population is at risk of dengue, cases of which have grown dramatically in recent decades. Yearly cases reported were over five lakh in 2000 and have increased to 52 lakh in 2019, according to the World Health Organization (WHO). Asian countries represent 70 per cent of the affected global population, even as the mosquito-borne disease is now endemic in over 100 countries from across Africa, the Americas and the western Pacific, according to the UN health agency. With climate change driving warmer temperatures and humidity around the world, the habitat of mosquitoes that carry the DENV virus is also expanding, leading to new dengue outbreaks in more countries, including those in Europe and the eastern Mediterranean. Prevention and control of dengue currently hinges on vector-control measures, and there is no specific treatment for the disease, according to WHO. Source: Pharma

Aug 13,2024 Mabwell, an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. This will help to expedite the development process of 9MW2821 and meet the unmet clinical needs of Chinese patients. 9MW2821 is the first site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and also the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer (CC), esophageal cancer (EC) and breast cancer. In 2024, 9MW2821 has been granted Fast Track Designation by FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has been granted Orphan Drug Designation by FDA for the treatment of EC, and also Breakthrough Therapy Designation by CDE of NMPA. 9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumour cells. Mabwell is an innovation-driven biopharmaceutical company, has the entire industry chain of R&D, manufacturing, and commercialization. The company is committed to provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Source: Pharmabiz

August 05,2024 Global pharma major Lupin Limited (Lupin) announced the successful completion of a global phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis. The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis. Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment used in the treatment of neovascular age-related macular degeneration (also called wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).  The l phase 3 study was designed as a global clinical trial, in line with recommendations from EMA and US FDA, to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with neovascular age-related macular degeneration. A total of 600 patients from India, US, EU and Russia were randomized in the study, who received either LUBT010 or Lucentis 0.5 mg, administered as an intravitreal injection once a month for 12 months. Patients were followed for efficacy, safety and immunogenicity assessment. The data from this phase 3 study will be part of Lupin’s application for marketing approval with the US FDA and the European Medicines Agency (EMA). “We are very pleased with the positive outcome of the global phase 3 study, which marks yet another significant developmental milestone for our Lucentis Biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs,” said Dr. Cyrus Karkaria, president of Lupin Biotech. “We will be filing marketing applications for LUBT010 in all major global markets this year.” Commenting on the milestone, Nilesh Gupta, managing director, Lupin said, “This achievement of our biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialized four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab biosimilar into the global ophthalmic market, making a positive difference in the lives of our patients worldwide.” Source: Pharmabiz

Aug 13,2024 Mankind Pharma, a reputed global pharmaceutical firm, has launched a comprehensive nationwide campaign to raise awareness about organ donation. The initiative, aligning with the company’s motto of “Spreading Kindness,” aims to address the critical shortage of organ donors in India, where the donation rate stands at a mere 0.86 donors per million population. On August 4, Mankind Pharma unveiled a powerful video campaign designed to educate the public about the importance of organ donation. The campaign highlights the life-saving potential of organ donation and seeks to dispel common myths surrounding the practice. As a cornerstone of this initiative, Mankind Pharma hosted a special program at its office on August 12, in collaboration with the National Organ & Tissue Transplant Organization (NOTTO) and leading medical experts. The event, which was broadcast live on YouTube, brought together all 22,000 Mankind Pharma employees in an unprecedented show of support for organ donation. Rajeev Juneja, vice-chairman & managing director, Mankind Pharma, stated, “At Mankind Pharma, we believe in the power of collective action to drive meaningful change. Our organ donation awareness campaign is a testament to our commitment to improving healthcare outcomes in India. By engaging our Mankindians and partnering with experts, we pay tribute to the compassionate heroes who choose to give the gift of life to others, and we urge everyone to spark a wave of change by choosing to be an organ donor today.” Sheetal Arora, chief executive officer & whole-time director, Mankind Pharma, added, “This campaign represents a significant step in our ongoing efforts to contribute positively to society. With only 0.86 donors per million and an alarmingly low number of registered donors in our country, choosing to be an organ donor is not just a personal choice but an act of spreading kindness. By leveraging our reach and resources, we hope to significantly increase the number of registered organ donors in India, potentially saving countless lives in the process. “ The live event featured insightful presentations from renowned medical professionals, addressing various aspects of organ donation. Dr Arvinder Singh Soin, chairman, Liver Transplant, Medanta Gurugram, discussed the myths and facts surrounding organ donation, stating, “Organ donation is often misunderstood due to various myths. It’s crucial to understand that one organ donor can save up to eight lives. By dispelling these misconceptions, we can encourage more people to become donors and potentially save countless lives.” Dr Anil Kumar, director, NOTTO provided an overview of the current scenario of organ donation in India, emphasizing, “With a low donation rate, India faces a severe shortage of organ donors. This campaign by Mankind Pharma is a significant step towards bridging this gap. By raising awareness and facilitating easy registration, we can dramatically increase the number of potential donors and give hope to thousands awaiting life-saving transplants.” The event culminated in a collective pledge by Mankindians to support organ donation, setting a powerful example for corporations across India. By recognizing the alarmingly low number of registered donors and paying tribute to those who give the gift of life, Mankind Pharma is leading a movement for change. The company’s organ donation awareness campaign is set to continue throughout the year, with additional initiatives and partnerships planned to inspire widespread participation across nation. Mankind Pharma is one of the largest pharmaceutical company in India, which focuses on the domestic market with its Pan India presence. Mankind operates at the intersection of the Indian pharmaceutical formulations and consumer healthcare sectors with the aim of providing quality products at affordable prices. Source: Pharmabiz

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