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

The Gujarat Food and Drug Control Administration (FDCA) has cancelled manufacturing licenses of 2 pharma companies based on risk-based inspections of 5 companies due to non-compliance to GMP norms and quality. The state drug regulator also canceled the license of one of the sections of a company that produced products which were unstable and multiple failures happened during quality testing and analysis. “Licenses were canceled because these companies could not produce the stability data as per the norms. We had to take the urgent decision to cancel licenses in the interest of public health,” informed Gujarat FDCA Commissioner Dr H G Koshia. The Gujarat FDCA had earlier cancelled 15 product licenses of 6 pharma companies based on risk-based inspections. In these risk-based inspections, it was revealed that the products of some of the companies, producing widely prescribed gastrointestinal medicines and vitamins, were not-of-standard quality (NSQ). Products also include oral rehydration salt (ORS) and medicines like azithromycin for cold and amoxicillin for bacterial infections and also antimalarial medicines. These risk based inspections are being done pan – India. NSQ medicines were also reported earlier this year from Uttrakhand, Himachal Pradesh (HP), Madhya Pradesh (MP), Andhra Pradesh (AP) and Gujarat. Licenses of 18 Indian pharma companies were cancelled based on the risk-based inspections planned in December last year. The Central Drugs Standard Control Organization (CDSCO) office was planning to undertake massive risk-based inspections pan-India following the World Health Organization (WHO) holding Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of children in Gambia and Uzbekistan. Around 76 pharma companies were inspected across 20 states/UTs by a joint team of the state and central licensing authorities in the past six months. The CDSCO had identified around 203 pharma companies and more than 25 pharma companies were issued show cause notices. Risk based inspection criteria is based on the number of sub-standard samples of the respective manufacturer found in the market in the past three years. The risk-based inspections are based on the current good manufacturing practices (cGMP) and good laboratory practices (GLP) under the Drugs & Cosmetics (D&C), Rules, 1945.These inspections which are jointly conducted by the state drug licensing authorities and the Drugs Controller General of India (DCGI) audits manufacturer’s compliance on sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination and bacterial contamination during production among other critical areas. Saturday, June 10, 2023 Source: pharmabiz.com

The Supreme Court on Monday said the Consumer Protection Act, 2019, is meant to encourage consumerism in the country and any technical approach in construing its provisions against consumers would defeat the objective behind its enactment. A bench of justices J K Maheshwari and M M Sundresh said a “pedantic and hyper-technical approach” would cause damage to the very concept of consumerism. The apex court’s observations came while dealing with appeals against a National Consumer Disputes Redressal Commission (NCDRC) order passed in a matter relating to completion of a housing project. The bench said the Consumer Protection Act has got a “laudable objective” and the 2019 law facilitates consumers to approach forums by providing a very flexible procedure. “It is meant to encourage consumerism in the country. Any technical approach in construing the provisions against the consumer would go against the very objective behind the enactment,” it said. The bench noted that the appellant before it is an flat allottees’ association registered under Section 6 of the Haryana Registration and Regulation of Societies (HRRS) Act, 2012, while the respondent is a builder tasked with the development of the housing project. In its verdict, the bench also observed that the association had approached the NCDRC alleging that the builder has failed in the obligation to construct and complete the promised flats within the timeline agreed upon and also questioning the additional demands raised. Later, a complaint was filed by the builder with the District Registrar of Societies alleging that the aims and objectives enunciated in the bye-laws of the appellant association were not in conformity with the HRRS Act, the top court noted. Referring to the details of the matter, the bench observed that the state registrar of Haryana had directed the association to amend its bylaws within six months indicating that any failure to comply would result in cancellation of registration granted already. The association did make an amendment which was duly registered by the Gurugram district registrar in November 2019, it noted. It also noted that subsequently, the Gurugram district registrar by an order in June 2020 put on hold the amendments, as certified earlier, on the premise that the period of six months granted expired. The registrar general of Haryana dismissed the appeal finding no error in the order of the state registrar, the bench observed. The bench noted that the appellant’s registration was not cancelled. It observed that later, the orders passed by the state registrar and the registrar general of Haryana in the matter were challenged before the Punjab and Haryana High Court along with an application for stay, and though, the matter was still pending adjudication, there was no interim order as of now. The bench noted that the appellant had filed an application bringing to the notice of the NCDRC the pendency of the writ petition before the high court. The commission had adjourned the matter awaiting appropriate orders in the petition, it noted. The association had approached the apex court seeking to set aside the NCDRC’s order. “Complaints have already been registered, and in any case, the issue pertaining to registration and the bye-laws has got no relevancy, particularly in light of the submission made by the counsel for the appellant that affidavits have been filed by individual allottees. A pedantic and hyper-technical approach would cause damage to the very concept of consumerism,” the bench said. It noted that even after five years, the appellant association is unable to proceed and the cases have not progressed. “In such view of the matter, the impugned orders are set aside, and the appeals are allowed. Pending applications, if any, are disposed of. The national commission shall proceed to hear the matters on merits, expeditiously,” the bench said. PTI ABA ABA ANB ANB Monday, May 15, 2023 Source: theprint.in

The government wants Indian executives to be appointed as chief executive officers, chief operating officers, chief financial officers, and chief technical officers in Chinese brands’ Indian operations, according to media reports. The Union government has asked Chinese mobile phone manufacturers to induct Indian equity partners in their local operations, according to three executives who attended meetings at which the matter was conveyed, as per a report by the Economic Times. Indian executives should be appointed as chief executive officers, chief operating officers, chief financial officers, and chief technical officers, according to the three sources. Additionally, the government has directed them to appoint Indian contract manufacturers, expand local manufacturing down to the component level through joint ventures with Indian businesses, and hire local distributors. There are Chinese distributors for some of the companies, the report added. According to the executives, Chinese companies have also been directed not to evade taxes in India and to comply with the law. In recent meetings held by the ministry of electronics and information technology (MeitY), top government officials discussed these issues with Chinese companies including Xiaomi, Oppo, Realme, and Vivo. Manufacturers’ lobby group ICEA represents manufacturers. The MeitY meetings came at a time when several Chinese smartphone manufacturers were under investigation for tax evasion and alleged illegal remittances worth thousands of crores. In addition to lobbying with the government, offline retailers have also sought to ensure that predatory online discounting does not occur. In addition to manufacturing operations, the government is seeking Indian equity partners for sales and marketing. There are currently wholly owned operations of Chinese smartphone companies in India. Realme’s global business president, Madhav Seth, said the government wants companies to take advantage of the local talent and ecosystem. “Such changes will enable higher value addition in the country and make businesses self-reliant,” as quoted in the report. He declined to share further details or confirm the meeting. Pankaj Mohindroo, chairman of ICEA, said the government wants to develop Indian skills and companies, and enlist local companies where possible. “For instance, it wants Indian distribution in place of foreign distributors,” said Mohindroo. “The minister (of state for electronics and IT Rajeev Chandrasekhar) is personally leading these and players in the industry are taking affirmative steps,” as quoted by ET. According to one of the executives cited, the government does not want the Chinese to have complete end-to-end control. “The Chinese companies should start sending India-made devices (for export), so that they become net foreign exchange positive.” He said the government also wants these companies to have a proper offline retail presence in place of their online-only strategy, the report added. India has grown its business by investing in local talent, developing a core of Indian managers and leaders, partners, and distributors. According to him, all local senior roles are held by Indians, and the company was one of the first to adopt the ‘Make in India’ initiative, locally producing an entire line of smartphones and televisions, including components, the report added. An industry executive said the government has asked Chinese firms to employ Indians for replaceable skills since electronics manufacturing creates a lot of jobs and enhances skillsets. Tuesday, June 13, 2023 Source: moneycontrol.com