Jago Grahak Jago

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

Recently, Thane additional district consumer disputes redressal commission held that banks can recover the dues from a credit card customer from the customer’s fixed deposit (FD) held by the bank. The district commission dismissed the plea by the card-holder after the bank contested that: The bank had reached a settlement with the card-holder to clear the dues in three instalments. Since the card-holder failed to clear the dues as per the settlement terms, the bank issued a notice to him and then exercised its right to recover the dues from his FD with the bank. Not happy with this judgement, the card-holder preferred to file an appeal before the Maharashtra state consumer disputes redressal commission. His argument was that the dues on his credit card were for the period up to 2006 and could not be recovered from his account in 2014 because the claim by the bank had been time-barred under the Limitations Act. He alleged that the bank recovered the money from his FD without his knowledge or consent. The state commission made an important observation that the card-holder had neither disputed issuance of the credit card, nor the dues against the card. The commission further held that, though the bank was barred by the Limitation Act for initiating legal remedy, it did have the right to recover the dues. So, the state commission dismissed the appeal by the card-holder and upheld the order in favour of the bank. What we gather from this news report is that the card-holder did not dispute his dues, he agreed for amicable settlement with the bank; but, since he did not follow the terms and conditions of the settlement, the bank exercised its right of set-off and the provisions of the Limitations Act, 1963 were not a hurdle in the recovery of bank dues. The Madras High Court had given almost a similar ruling on 18 June 2016. Justice M Venugopal had dismissed a writ petition filed by a retired Tamil Nadu Electricity Board employee, who sought to restrain a nationalised bank from recovering the farm loan dues from his pension amount in the savings bank account. We need to know a little more about the credit card dues and their recovery, about the right of set-off and about certain limitations under some Acts. Here, let me clarify that I am not a lawyer. I will try to explain various provisions from the view of a banker and a common man and in a broader sense. We must first understand the working of a credit card. As the term denotes, credit card facilitates the card-holder to make various payments on credit. A bill is generated at the end of the period during which such purchases are made and contains all the transaction details informing the card-holder to pay the dues by a specific date. It also explains various terms and conditions. One must understand that the card-issuing bank is settling these payments out of its own funds, which is as good as a loan given to the card–holder, and the credit card limit is nothing but a loan limit. The dues should be paid on or before the due date to avoid attracting penalty and hefty interest. If the dues are high, they can be converted into equated monthly instalments (EMI) on certain terms and conditions, if the card-holder is not in a position to pay the dues in one go. In the above-mentioned case, the bank and the card-holder even reached an amicable settlement of paying the dues in three instalments. However, since the dues were not paid as agreed upon, the bank had to initiate its right of set-off. A right of set-off is a right to set off a debt due to someone against a debt due from the same person. In other words, this is combining and netting two accounts. As an example, suppose I owe Rs10,000 to Mr A and, at the same time, Mr A owes Rs9,000 to me. Here, I can exercise the right to set off my dues to Mr A to the extent of Rs9,000 and pay him the balance of Rs1,000. Indian Contract Act, 1872, has discussed the right of set-off in detail under various Sections with examples. Sections 59, 60 and 61 deal with appropriation of payment. Section 59 deals with payments where the debtor specifies application of payment to a specific debt. Section 60 says that if the debtor has not mentioned anything specific, the creditor will apply the payment as per his discretion to any lawful debt of his choice, which has actually fallen due and whether it is or is not barred by any law of in force. As per Section 61 where neither party makes any choice for appropriation, the payments will be applied in discharge of the debts in order of time and, again, whether or not, they are barred by the law in force. For example, assume A has lent to B Rs10,000 on 1.1.2023, Rs5,000 on 17.2.2023, Rs7,000 on 15.3.2023, and so on. First payment of, say, Rs9,000 by B will go to settle the first debt of 1.1.2023. Any next payment will first be adjusted against the balance Rs1,000 of the first debt and the remaining amount will be adjusted against the second debt. If instead of Rs9,000 B pays Rs12,000, then Rs10,000 will fully go to settle debt of 1.1.2023 and balance Rs2,000 will go to adjust debt of 17.2.2023; and so on. While loans are repaid by fixed instalments, cash credits and overdrafts are running accounts. So, to avoid any complications, banks obtain ‘Letter of Continuity’ or ‘Letter of Continuing Security’ so that the earliest debts get appropriated with every subsequent deposit. Apart from the above three Sections, Section 171 of the Indian Contract Act explains general lien, inter alia, of bankers. It says that “in the absence of any contract to the contrary, they can retain as a security for a general balance of account any goods bailed

Upholding orders passed by the fora below, the national consumer dispute redressal commission (NCDRC) asked New India Assurance Co Ltd to pay an insurance claim of Rs5 lakh to the family of the deceased holder of a debit-cum-ATM card from Axis Bank. In an order issued last week, the bench of Subhash Chandra (presiding member) says, “This Commission, in exercise of its revisional jurisdiction, is not required to re-assess and re-appreciate the evidence on record when the findings of the lower fora are concurrent on facts. It can interfere with the concurrent findings of the fora below only on the grounds that the findings are either perverse or that the fora below have acted without jurisdiction. Findings can be concluded to be perverse only when they are based on either evidence that have not been produced or based on conjecture or surmises i.e. evidence which are either not part of the record or when material evidence on record is not considered.” New India Assurance had filed a revision petition against orders passed by the district consumer disputes redressal forum at Panchkula and the Haryana state consumer disputes redressal commission. Manoj Kumar from Panchkula in Haryana had, on 7 October 2011, opened a savings bank account in Axis Bank. As per the scheme of Axis Bank, a debit-cum-ATM card was issued to Manoj Kumar. Axis Bank had a credit card package insurance policy with New India Assurance covering the risk of lost card liability and personal accident insurance, subject to eligibility criteria and exceptions of the policy. On 18 November 2011, Manoj Kumar died in a road accident. As his nominee, his father, Jagdish Chand, approached Axis Bank to pay the accident insurance claim. The Bank informed Jagdish Chand about the procedure to file a claim with the insurer. On 5 July 2012, he issued a legal notice to Axis Bank. However, New India Assurance alleged that Mr Chand and his wife, the nominees of Manoj Kumar, neither followed the procedure for the claim nor fulfilled the eligibility criteria but sent the documents to Axis Bank on 17 July 2012, which were merely forwarded to the insurer on 19 July 2012. Mr Chand and his wife made several futile efforts to have the claim released; however, Axis Bank did not honour the claim which amounted to unfair trade practice and deficiency in service and caused mental agony and harassment to them. They then filed a complaint before the district forum. Axis Bank contended that the formalities of filing all documents with the claim within 10 days of the date of death had not been done, and only documents were filed on 17 July 2012. It was stated that the insurance cover was an additional facility provided by the insurance company and there was no contract between or agreement between Mr Chand and his wife and Axis Bank, and the claim was to be settled by the insurance company. New India Assurance also denied the allegations and submitted in its written statement that Manoj Kumar had an accident insurance cover of Rs2 lakh with it. It denied that any transaction had been made with the debit card and, as the death was within 42 days of the opening of the account, he was not entitled to any personal accident insurance coverage benefit. New India Assurance also contended that though the death occurred on 18 November 2011, Mr Chand and his wife submitted the requisite papers to the insurance company after 243 days on 19 July 2012. Given the delay, New India Assurance says there was no liability on the insurer to pay the claim. The insurer also contended that the accident cover policy was applicable only if a successful payment transaction at any merchant outlet was made within 90 days before the incident, which had not been proven in the case of Manoj Kumar. In its order on 24 September 2013, the district forum allowed the complaint. It directed New India Assurance to pay the insurance amount of Rs5 lakh under the policy along with interest at 9% per annum from the due date till the actual payment. Axis Bank was directed to pay a lump sum compensation of Rs10,000 to Mr Chand and his wife for mental harassment and litigation cost. New India Assurance challenged the order before the state commission. While dismissing the appeal, the state commission pointed out that Mr Chand and his wife approached Axis Bank in December 2011 and submitted all relevant documents, such as the post-mortem report, death certificate, copy of the first information report (FIR) and other documents. They were advised to open a new account to transfer the balance in the account of Manoj Kumar, which was done on 20 December 2011. Axis Bank did not deny these facts. New India Assurance also did not deny providing insurance coverage of Rs5 lakh for accidental death. “Merely because some prescribed forms were not filled up, cannot be a ground to repudiate the claim, particularly when at least the initial formalities were completed by the complainants,” the state commission says in its order on 25 February 2014. New India Assurance then filed a revision petition before NCDRC. After hearing both the parties and carefully considering the material on record, Mr Chandra from NCDRC observed that New India Assurance has not denied that there was a personal accident insurance policy linked to the debit card issued by Axis Bank to the deceased son of Mr Chand and his wife. “However, it is their case that there was no privity of contract between the deceased card holder and New India Assurance. It is also argued that the claim of insurance was filed very late by the Bank and that the eligibility criteria of a valid transaction at a merchant outlet at least 90 days prior to the incident had not been met,” the bench noted. The counsel for Mr Chand and his wife submitted that the lower fora have arrived at concurrent findings which have attained finality