The Aware Consumer

In order to achieve quality, compliance and patient safety, the Central Drugs Standard Control Organisation (CDSCO) is rationalising the drug regulations in consultation with global regulatory experts. This, according to the Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi, will be done towards ease of doing business and developing a quality culture. Speaking on the sidelines of a panel discussion on Quality, Compliance and Patient Safety at the 9th International Pharmaceutical Exhibition (iPHEX) in Hyderabad, the DCGI said this is very much required as the pharma industry is projected as a US$ 500 billion opportunity by 2047. The event which was hosted by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry began on July 5 and concluded on July 7, 2023. “Regulations need to be designed in such a manner that it serves the purpose of quality for both big pharma and MSMEs. It has been observed that the compliance to drug regulations have been optimal for big pharma and sub -optimal for MSMEs. Besides that, it has also been observed that there has been non-uniformity in terms of interpretation and implementation of the law. Therefore, MSMEs will be supported by the CDSCO towards upgradation of skills to achieve global industry standards,” the DCGI said. “Creating a balance in terms of implementing the law is a challenge as the country’s compliance requirements are huge considering the size of the industry and the country. This is also very much required as India is witnessing and implementing global regulatory harmonisation with active participation of the US, Europe and Japanese pharmacopeias,” Raghuvanshi added. He further said that India story will continue to shine if we allow MSMEs also to move up the value chain by bringing in quality manpower and setting quality management systems (QMS). “In order to create an ecosystem of quality, the Indian Pharmacopoeia Commission (IPC) has developed Adverse Drug Reaction (ADR) reporting form as a part of the Pharmacovigilance Programme of India (PvPI) to effectively report adverse events due to the usage of a medicinal product. Over the past ten years of inception of PvPI, it has generated 13 signals which is big milestone to achieve and hundreds of drug alerts,” Raghuvanshi informed. Lakshmi Prasanna, director, Regulatory Affairs, Pharmexcil conducted the proceedings of the event. Monday, July 10, 2023 Source: pharmabiz.com

The Indian pharmaceutical industry is expected to grow at 7-8 per cent in FY24 to FY25 with prospects to reach $57 billion by FY25, after registering a Compound Annual Growth Rate of 6-8 per cent during FY18 to FY23, according to CareEdge Ratings. In a latest report, the knowledge-based analytical group said that the Indian pharma industry has grown from $35.41 billion in FY18 to $49.78 billion in FY23 and is likely to reach $57 billion by FY25. Globally, the Indian pharma industry has a strong footprint in the generics segment and the pharma exports and domestic market contribute equally to the overall Indian pharma industry. The growth during FY18-FY23 was contributed by 8% growth in exports and 6% growth in the domestic market during the same period. “The Indian pharma industry is expected to see a growth of around 7% to 8% over FY24-FY25 while the operating profitability of formulation companies to improve to around 23-23.5% and that of APIs/bulk drug companies to improve to around 19-20% during the same period,” said Krunal Modi, associate director at CareEdge Ratings. “The Indian pharma sector is expected to grow at a steady pace in the medium term due to structural factors such as ageing of the population, rising lifestyle or chronic diseases, healthcare awareness and insurance penetration apart from increasing government spending under various schemes,” said Modi. Further, changing world demography along with complex and specialty generic products are expected to drive the export growth of Indian pharma companies. The export growth would also be supported by patent expiry in regulated markets. Going forward, CareEdge Ratings expect higher export growth rates for emerging markets compared to growth rates of developed markets, it added. The Indian pharma market grew by nearly 5% on a year-over-year basis to $49.78 billion in FY23. The exports grew by just 3% while the domestic market continued to grow at a healthy rate of 7% in FY23 over FY22. Within exports, the emerging markets were largely flat while the developed market registered a growth of around 8% in FY23 on a y-o-y basis. The exports to emerging markets were impacted due to the Russia-Ukraine war and a shortage of foreign currency in many African countries apart from the significant depreciation of their local currencies. Regulatory headwinds and consequent lower ANDA approvals are likely to constrain the exports to developed markets. However, increasing focus on synthesis segment, complex and specialty products apart from easing of pricing pressure in US generics are likely to support the growth in the medium term. The US holds a prominent position as one of the largest export destinations for the Indian pharma industry, accounting for approximately 30-35% of total formulation exports. In recent years, the US generics market has experienced significant price corrections due to the consolidation of buyers and distributors. Despite these challenges, CareEdge Ratings has observed a notable increase in US export sales volumes, with expectations of sustained growth driven by upcoming patent cliff opportunities, said the report. In FY23, formulation exports to the US recorded a growth of 5.9%, primarily supported by sales volume growth of around 16%. However, this growth was partially offset by a price erosion of around 10-11%. The pricing erosion in the US generic market has eased to low single digit, a significant improvement compared to the high double-digit erosion witnessed in the past two years. “Looking ahead, there are substantial opportunities on the horizon, as approximately $188 billion worth of drugs worldwide are set to go off-patent during the period from Calendar Year 2023 to Calendar Year 2026. This presents a favourable landscape for the Indian pharma industry to capitalize on these patent expirations and expand its market share,” it said. During FY23, the Indian pharma exports stood at $25.39 billion which includes APIs/bulk drug exports of $5.32 billion. After witnessing sharp rise in APIs/bulk drug exports during FY21 due to Covid-19 led supply chain disruption in China, the exports of APIs/bulk drugs have remained subdued during FY22 and FY23. The export of bulk drug/APIs is likely to grow at around 5-6% over FY24- FY25; in-line with its historical average, it added. Despite sustained pricing pressures in the US generics market, formulation companies could sustain their margins to around 22% in FY23 due to focus on complex and specialty products. The operating margin of APIs/bulk drugs companies declined by nearly 170 bps on a y-o-y basis and stood at around 18% in FY23. CareEdge Ratings expects the growth in FY24-FY25 would be supported by 6% to 7% growth in exports and 8% to 9% growth in the domestic market during the same period. The credit profile of Indian pharmaceuticals companies in general has remained stable historically, due to their strong profitability and lower reliance on debt which is likely to continue. During the pre and post-Covid periods, the Indian pharmaceutical industry experienced significant changes in its operating profitability (PBILDT) margin. In FY21, due to the Covid-19 pandemic restrictions, there was a noticeable reduction in marketing, travelling, and conveyance expenses. Coupled with increased sales opportunities related to Covid-19, this resulted in a substantial increase in operating margins for the industry. However, the subsequent years, FY22 and FY23, presented new challenges for the pharma sector. Elevated input prices, rising freight costs, extended delivery timelines, and competitive pressures in the US generics market led to a moderation in operating margins. “As we look ahead, there are positive signs for the industry. Raw material prices are stabilizing, freight rates are normalising, and pricing pressure in the US generics market is easing. These factors are expected to contribute to an expansion of operating margins by approximately 100 to 150 basis points over FY24-FY25 compared to FY23. Furthermore, the industry’s continued focus on launching specialty and niche products in the US market is anticipated to provide further support to the profitability,” it added. Tuesday, July 11, 2023 Source: pharmabiz.com

SaSPinjara Life Sciences, the technical and business consultation provider for the pharma business in the global market, now sees that for Indian companies, China regulation is still very complex. Only companies with experience in the Chinese market have a certain advantage. It will take at least five years from the establishment of a joint venture to the final launch of the product, as drug approval takes three years. Indian companies also need to develop drugs targeting the Chinese market, which is another challenge, said Sachin Marihal, co-founder and chairman, SaSPinjara Life Sciences. India’s top pharmaceutical companies have always regarded the United States as their main market and have been unable to open up trade in China for a long time, with government regulation being the biggest obstacle, he added. Agreeing with Marihal was Aravind P, chief technical officer, SaSPinjara Life Sciences who said that even after policy reforms by the Chinese regulatory authority, still companies from India face  challenges in registering into this market, as compared to the US and EU regions. China is currently a semi mature market compared to the United States.  Indian multinational pharmaceutical companies, entering the Chinese market now have a great opportunity. This is because a wide basket of medicine portfolio has entered the list of volume based centralized procurement in China, Marihal told Pharmabiz. There is a huge market potential in China. To this end, Pharmacodia Global Data base has initiated its state-of-the-art incubation center in China, which will help to provide land, ready facility, investment, government funding, market access, regulatory access, joint venture opportunity and all related support to international companies for better long-term strategy growth, noted Aravind. Currently, Saspinjara has positioned itself as a channel partner to enter China and has just opened business avenues for Indian pharma. The company has been in discussions with a couple of Indian pharma companies during the recent CPhI Shanghai 2023 held in mid-June to help them better understand China market, investment, regulatory, disease mapping and related access strategy. On how interested Indian pharma companies would be keen to invest in China with the ongoing Union government’s Make in India programme gaining momentum, Marihal and Aravind noted that the support provided varies in different regions of China. It is important to ensure that the interests of foreign investors are protected. This includes establishing a mechanism for optimizing the legal protection of the business environment, actively creating a fair market for domestic and foreign companies to compete.  There is need to ensure that foreign-invested enterprises have equal access to production factors such as human resources, capital, land use rights, and natural resources in accordance with the law, and participate in market competition fairly, they added. Compared to other regulated markets, China is the most stringent in regulations for pharmaceutical products and volume of products requirement is also high.  There are many different business models where several opportunities are available for foreign companies to utilise. Here the Pharmacodia Global platform can help companies to enter China, said Marihal and Aravind. Tuesday, July 11, 2023 Source: pharmabiz.com

The United States Pharmacopoeia (USP) has set up a programme unit team on excipients with a mandate for fiscal 2024 on the specific areas of di-ethylene glycol (DEG) and ethylene glycol (EG). The plan envisages contributing in testing excipients and also helping enhance criticality of testing methods in collaborations with USP headquarters in the US. This comes close on the heels of the Central Drugs Standard Control Organization (CDSCO) office conducting massive risk-based inspections pan-India following the World Health Organization (WHO) holding Indian pharma companies accountable for exporting contaminated cough syrups in Gambia and Uzbekistan due to the presence of excipients like DEG and EG in the cough syrups. “Excipients have a direct correlation with patient safety so it becomes very important to test excipients. Traditionally, excipient testing was done keeping in mind the end use in the drug product but that has changed over the past several years. So ideally it should not be tested into the end product but it has to be built in the end product. Quality by Design (QbD) is the way to go when you formulate a particular product so that one can counter and mitigate the risks involved considering that excipients have a lot of functional role to play in several drug products,” said Girish Kapur, vice president (VP), India Site Operations and Site Head, USP on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) held in Hyderabad organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry between July 5 and July 7, 2023. “USP as a standard setting organization realized this change and the dedicated expert committees on excipients now focus on excipient characterization, excipient variability, performance and the composition as well. USP has several general chapters which very well elaborate on how you can test different excipients in the lab. Besides this, there are 500 plus excipient monographs in the National Formulary (NF). NF has the maximum number of monographs and more than 60% of them have physical reference standards as well,” informed Kapur.  He further added that Covid has taught us the importance of supply chain. Given that the excipient supply chain is very complex and now with the advent of complex generics in the pharma industry, more excipients which will now be novel and not the regular ones like starch, CMC and HPMC among others. This will make the supply chain more vulnerable for adulteration. It is also important because we will use the excipient in the drug product and this will eventually affect the drug quality. “USP is very well integrated with its US counterparts with a big lab set up in Hyderabad in India. As a standard setting organisation, USP believes that the public standard setting process has to be based on a robust public input system which can give feedback on monographs published in the USP and the NF. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients. USP is an official quality standard for medicines marketed in the US,” Kapur informed. USP–NF is a combination of two compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. “Excipients form 90% of the dosage forms available in the market. The role of excipients is very important as they impart a lot of physical characteristics to the drug product in terms of flowability, compressibility, disintegration and controlling the drug release in the product. In some cases, they also influence the organoleptic properties like taste and texture among others. These are the important parameters for evaluating the drug product which is sold in the market,” Kapur concluded. Tuesday, July 11, 2023 Source: pharmabiz.com

The Delhi High Court has refused to grant interim injunction in favour of Bayer Healthcare LLC in a patent litigation against Natco Pharma and MSN Laboratories in which the former has sought interim injunction against the two Indian companies from infringing the patent rights of its anti-cancer drug regorafenib, branded in India as Nublexa and Resihance. The Court, considering the arguments, took public interest into consideration and noted the price difference between the patented product and the products from the Indian generic firms, and also that a genus patent technically covering the compound has already expired patent protection in the country, while rejecting the application for interim injunction. The drug, which is branded as Stivarga in countries such as United States, European Union, China and Japan, is an oral, prescription anticancer medication approved by the US Food and Drug Administration (FDA) for people with cancer such as colon or rectal cancer, a rare stomach, bowel or oesophageal cancer known as gastrointestinal stromal tumour (GIST) and a type of liver cancer called hepatocellular carcinoma. Bayer Pharmaceuticals, the Indian affiliate of Bayer Group, has obtained an import license on June 1, 2014 and has been selling the regorafenib under the brand names Nublexa and Resihance in India since 2015. Bayer claimed that it has a patent for the compound with a validity for 20 years from July 22, 2004. The company also had a genus patent approved for carboxyaryl substituted diphenyl ureas, covering a vast number of compounds and this expired in January 12, 2020. While regorafenib is not specifically disclosed in the genus patent by way of either chemical name, formula, or chemical structure, it is technically covered within the generic scope of the numerous compounds included in the Markush Formula disclosed in the patent, it said. Natco and MSN Labs argued that the patent under dispute is already disclosed in the genus patent as the salts and the compositions and Bayer had prior knowledge of the compound regorafenib at the time of filing of the genus patent. They argued that the company deleted many compounds including regorafenib while amending its description of IN ‘758, due to which the said compounds entered into the public domain. They argued that regorafenib being disclosed in the patent IN ‘758, which expired on January 12, 2020, any corresponding protection to the compound also expired on the same date and no injunction can be granted against Natco and MSN Labs. The Court, after hearing both the sides, observed that Bayer, having admitted that the patent under dispute is covered by the genus patent – though qualifying such admission by use of the world “technically” – whose term has admittedly expired, at least prima facie is not entitled to an interim order at this stage. “The public interest would also demand that such injunction be refused inasmuch as it is claimed that there is a huge disparity between the price of the product offered by the plaintiff (Bayer) and the defendant (Natco and MSN Labs) for a disease which is life threatening,” said Justice Navin Chawla in an order on July 5, 2023. In the present case, Bayer is selling their product at the range of Rs. 36,995 by importing the same into India, whereas, the defendants are manufacturing the product in India and selling the same at a cost of Rs. 9,900. “Undeniably, the products of the defendants are significantly cheaper than that of the plaintiffs. Public Interest would demand that large segments of population should have relatively easier and affordable access to an anti-cancer drug, which could be the difference between life and death for certain patients. Taking into account the nature of the disease and the drug it seeks to provide relief from, affordability plays a major role in its access to wide sections of the public. Therefore, it would not be appropriate to injunct the defendants from selling the said product, especially when a creditable challenge to the patent has been laid and the plaintiff has already enjoyed protection for its full term for IN ‘758, that is, the genus patent,” said the Court. In order to maintain the balance of convenience, the defendants were directed to maintain complete accounts of manufacture and sale of the products with the subject patent and file statement of accounts, on affidavits on a half yearly basis before the court. Tuesday, July 11, 2023 Source: pharmabiz.com

RBI noted the rise in complaints regarding credit bureaus while proposing measures to bolster consumer protection. The Reserve Bank of India has proposed a slate of measures to bolster consumer protection following the recent inclusion of credit information companies, or credit bureaus, under the central bank’s regulatory umbrella. With the increase in customer complaints regarding credit information reporting and the functioning of credit information companies, it has been decided to put in place a comprehensive framework for strengthening and improving the efficacy of the grievance redressal mechanism and customer service provided by credit institutions and CICs. The measures proposed by the RBI on Thursday include: A compensation mechanism for delayed updation or rectification of credit information. A provision for SMS or email alerts to customers when their credit information is accessed from CICs A time frame for the ingestion of data received by CICs from credit institutions. Disclosures relating to the number and nature of customer complaints received on the website of CICs. “These measures will further enhance consumer protection,” RBI Governor Shaktikanta Das said, in his statement announcing the measures on April 6. Detailed guidelines regarding the proposals will be issued shortly, the RBI said in a statement. CICs were also brought under the aegis of the Reserve Bank’s Integrated Ombudsman Scheme in October 2022. Thursday, April 6, 2023 Source: bqprime.com

It is notified for information of all the concerned that all types of cases, namely, Consumer Complaints, First Appeals, Revision Petitons, Execution Applications, Appeal Executions, Second Appeals, CCPA Appeals, etc., shall, henceforth, be compulsorily filed through online mode/e-file through the portal https://edaakhil.nic.in. Tuesday, June 6, 2023 Source: ncdrc.nic.in

Indian pharma is looking for reliability, compliance and high-end visibility across the supply chain, said Vishal Barnabas, vice president, consumer & manufacturing business, Mahindra Logistics. There has been a significant increase in the complexity of pharma supply logistics in the recent years. The Covid pandemic further augmented that complexity in managing pharmaceuticals going by the raw material distribution and scattered manufacturing across the globe. The coordination across all these touch points is what makes pharma supply chain entirely complex, he added. What is required to manage pharma supply chain is the completely customised solutions. This is because of the challenges faced by pharma supply chain include disruptions, inventory management, and compliance with regulations. Of late, disruptions with geopolitical conflicts further add to the supply chain pressures. All these instabilities result in shortage of raw materials and manufacturing gets disrupted. Besides, inventory of pharma is almost handled like perishable goods. Expiry dates and temperature control issues add up to the difficulties, he said. From a perspective of supply chain logistic players, the biggest challenge in inventory is balancing supply and demand. For example, forecasting supply chains and the ability to maintain these at optimal is one of the biggest challenges. This is where technology adoption comes to play like artificial intelligence and tools for demand forecasting, Barnabas told Pharmabiz. Companies like Mahindra Logistics adhere to stringent Good Distribution Practices (GDP) norms. Our high quality control mechanisms, documentation, coordination are in sync. In technology apart from AI, big data analytics enhance visibility, chatbots, IoT (Internet of Things) devices and RFID (radio frequency identification) tags are deployed to enable quick responses, he said. Since pharmaceuticals are known for their short shelf life, here extensive product movements are self-controlled to spot the goods in the supply chain system. Even some of the vehicles have got smart locks which are GPS connected indicate the exact location regularly. Also it controls pilferages as these are all operated by apps, noted Barnabas. In an effort to stay ahead of the curve, we have an incubation programme for start-ups to come up with novel ideas. Our programme ‘Catapult’ see us engaging with start-ups that work on blockchain. Going forward we will experiment with their products and if viable will commercialise it to be deployed across various our businesses, he said. The company’s recently started its international operations to Dubai. But is a key players on-road in India. Its warehouses are on long-lease with controlled areas, managed with technology. Primary many Indian pharma companies are still not using logistic companies or controlled temperature routes. We are in talks with companies to highlight the indispensability of trace and track, high-end visibility on movement throughout the supply chain, he said. Emerging trends in pharma supply chain are sighted as companies are already looking out for reliability and compliance. With the Make in India and production linked incentive (PLI) scheme pharma companies are encouraged to consider integrated solutions supply chain solutions in a quality controlled environment. Therefore the future is upbeat in pharma supply chain logistics, said Barnabas. Friday, June 9, 2023 Source: pharmabiz.com

The drug price regulator has formulated guidelines to handle applications from the marketers seeking change in manufacturer for the formulations for which retail price has already been notified and product launched in the market, in future. The step has been taken to reduce the increasing instances of companies changing the manufacturers with or without informing the authority. The National Pharmaceutical Pricing Authority (NPPA) has decided that all future cases of change of manufacturer shall be examined on a case-to-case basis based on five parameters and only if the particular case falls within the ambit of these parameters the change may be permitted. The change of manufacturer may be allowed if there is cancellation or seizure of license of the manufacturing company; natural calamity or civil riots leading to destruction of plant of manufacturing company; dissolution or winding up of the manufacturing company; closure of the concerned business segment by the manufacturing company, etc; or any other circumstance(s) proved to be beyond the control of manufacturer or marketer. “The onus to prove the above conditions requesting for change of manufacturer will be on the applicant company with documentary evidence. The requests will be examined on a case-to-case basis and the earlier cases may not be treated as a precedent for future cases,” said NPPA. The pricing authority, in the past, has allowed the marketing companies to change the manufacturer after approval of retail price in some of the cases, keeping in view of the unavoidable circumstances highlighted by the marketing companies in their submission to NPPA and this has triggered more companies coming up with such requests. Earlier, Novartis India Ltd had approached the NPPA for its Voveran 1ml AQ – for which the retail price was fixed in May 31, 2019 with Nitin Life Sciences Ltd as manufacturer – informing that in order to support environmentally sustainable business through reduction in supplier footprint, in line with the company’s commitment as per the Environmental Social and Governance (ESG) Policy they plan to get the drug manufactured from another manufacturer Sovereign Pharma Ltd, Daman under the existing brand. It also proposed changes in six to seven excipients, which was later confirmed by the drug regulator as not substantial and does not require a separate license. Based on the information submitted, the Authority permitted the change in manufacturer. “This was also keeping in view the overall vision of the government for promoting Ease of Doing Business,” said NPPA after its latest Authority meeting. However, the Authority said, it has observed that subsequent to the application of Novartis, companies started applying to NPPA on a routine basis for change of manufacturer and are now merely intimating about the change citing reasons including change in business strategy, planning to manufacture the formulation at their own plan, etc. The Authority also permitted Gujarat-based Torrent Pharmaceuticals Ltd to change the manufacturer for its chlorthalidone 12.5mg + telmisartan 40 mg tablet. The company drew attention to certain guidelines set through an office memorandum in November, 2017 and the authority decided that in case the applicant marketing company intends to change the manufacturer for a formulation having the same brand for which retail price has already been provided, it may be allowed to continue to market the formulation with the same brand with the changed manufacturer at the price not exceeding the present applicable retail price. Torrent Pharma later again approached the Authority informing that due to change in business strategy, it proposes to manufacture brands Rosucor Gold 10 and Rosucor Gold 20, which were manufactured by Synokem Pharmaceuticals and approved by the NPPA, on their own under the existing brand. The Authority permitted the change in manufacturer for these brands also, subject to certain conditions. “The Authority noted that the change of manufacture was allowed to the companies keeping in view the provisions of the DPCO, 2013, the guidelines and specific circumstances of the company concerned. However, it is observed that companies are making it a routine affair and have started making unauthorised use of the same without seeking permission from NPPA,” it observed. It was based on these discussions and deliberation on the implications of such developments, the Authority has now come up with the guidelines. Tuesday, June 13, 2023 Source: pharmabiz.com

Insurers directed by IRDAI to establish ABHA IDs: The insurance regulator of India has recently released a directive to all insurers operating in the country to establish unique 14-digit ABHA IDs The insurance regulator of India has recently released a directive to all insurers operating in the country to establish unique 14-digit identifiers, known as Ayushman Bharat Health Account(ABHA) IDs, for all individuals residing within India. This new rule applies to both fresh insurance applicants and established policyholders. A key advantage of the ABHA ID is that it allows people to digitally authenticate, access, and manage their healthcare information, which can make scheduling hospital and doctor appointments a quick and easy process.This feature comes as a boon to patients who would otherwise face long waiting times for registration at medical facilities.The ABHA ID is a component of the National Health Authority’s Ayushman Bharat Digital Mission (ABDM), which aims to digitize healthcare records. At present, 402.6 million ABHA IDs have been generated by the NHA, and the goal is to offer this unique ID to all Indians. Monday, June 12, 2023 Source: currentaffairs.adda247.com