The Drugs Controller General of India (DCGI) has issued an advisory urging patients and healthcare professionals against the use of Digene Gel post the voluntary recall initiated by Abbott. Recommending an immediate halt in its use, the advisory states, “Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product.”

The advisory strongly advises consumers and patients to discontinue the use of Digene gel manufactured at Abbott’s Goa facility. It also directs wholesalers and distributors to remove all batches of the product from the distribution network that were manufactured at the Goa facility and are still within their active shelf life.

State drug controllers have also been told to closely monitor the movement, sale, distribution, and stock of these specific drug products in the market. “If said product lying in the market initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder,” instructs the DCGI letter.

“Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odour. There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs are not impacted and Digene Gel manufactured at our other production site is not affected and continues to be available in sufficient quantities to meet current demand,” informed a statement from Abbott.

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Gilead Sciences announced that the US Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in US studies evaluating magrolimab to treat acute myeloid leukemia (AML).

The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).

Effective immediately, screening and enrollment of new study participants under the US investigational new drug application (IND 147229) and US Expanded Access Program will be paused. Patients already enrolled in AML clinical studies may continue to receive treatment and be monitored, according to the current study protocol. Global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDA’s decision. Studies of magrolimab in solid tumours continue without any impact from the FDA action.

Gilead informed that it is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies.

Magrolimab is an investigational agent and has not been approved anywhere globally. Its safety and efficacy have not been established.

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There was a substantial backlash from major pharma trade associations and companies to the European Commission’s (EC) feedback initiative on the introduction of a pan-European compulsory license, which would allow for the invalidation of existing drug patents across the European Union (EU) in emergency situations. This could lead to further revision of the proposal, says GlobalData.

Jay Patel, Pharma Analyst at GlobalData, comments, “The pharma industry’s response to the feedback initiative has been overwhelmingly negative. Several responses drew attention to the question of defining emergency situations, which remains vague in the legislation. Not only did the European Pharmaceutical Industries and Associations (EFPIA) maintain its generally critical line towards the EU’s pharma strategy reform package, but its US counterpart, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed its support for the EFPIA position and its scathing disapproval of EU-wide compulsory licensing.”

Both Johnson & Johnson and Pfizer criticised the changes by referencing the positive role of patents in incentivising their vaccine production during the COVID-19 pandemic. In 2022, there were $37 billion in global sales of Pfizer’s Comirnaty and over $2 billion of J&J’s Jcovden. Even generics giant Teva Pharmaceuticals – a potential beneficiary of the reform – echoed the innovative drug developers’ preference for a voluntary licensing scheme. The consistency of this industry response highlights the potential global implications of the EU’s proposal.

The industry response follows a similar backlash from the government of Germany, which hosts three of the world’s largest pharma companies – Bayer, Boehringer Ingelheim, and Merck KGaA. Pharma companies may be able to use their relationships with national governments and Members of the European Parliament (MEP) to influence the outcome of this proposal.

Patel concludes, “There is still opportunity for changes within the EU’s legislative process. Firstly, the proposal has not been finalised, and the ultimate version presented by the EC after next year’s European elections may include industry concessions. In addition, there will also be possibilities for the European Parliament and the Council of Ministers to reform and amend this legislation before it is passed. However, as it is a regulation, it will be implemented immediately upon EU passage, without the option for further revision in the member state legislatures.”

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The global pharma industry is bracing itself for more headaches in its most profitable market as US House Democratic health leaders introduce new legislation, which would expand the Inflation Reduction Act and further lower prescription drug prices. House Democrats Frank Pallone Jr., Richard Neal, and Robert Scott unveiled the Lowering Drug Costs for American Families Act, in an effort to build on the Inflation Reduction Act and further lower healthcare and prescription drug costs for Americans. As a result, the pharma industry is set to face more pricing pain going forward, says GlobalData.

Cyrus Fan, Pharma Analyst at GlobalData, comments, “The Lowering Drug Costs for American Families Act proposes to expand the Inflation Reduction Act through three different ways. The bill proposes to expand the drug price negotiation program to all Americans with private health coverage, apply the inflation rebates under the Inflation Reduction Act to individuals covered by private health plans, and increase the number of prescription drugs selected for negotiation from 20 to 50 drugs.”

Gustav Ando, VP of Pricing and Market Access at GlobalData, continues, “In a double whammy, the proposal would double the number of drugs that would face price negotiations, and expand the scope into the private insurance market. It shows that far from being scarred by recent litigation from the pharma industry against the original legislation, the government is aiming to go even further in cutting US drug prices, which are typically the highest in the world.”

Fan continues, “An expansion of the Inflation Reduction Act is unsurprising from the Democrats, given the possible significant savings it will generate to Medicare. The legislation is another attempt by the Democrats to lower the costs of prescription drugs for more Americans. This time, the legislation targets the private sector, which would include 164 million people and their families and 26 million on marketplace coverage, along with those under Medicare coverage. The extension on the inflation rebates could also mean privately covered US workers can save a possible $40 billion over the next 10 years.”

However, the pharma industry has already reacted negatively to the legislation, citing that these proposals will give the government full control over the US healthcare system—including the private market. Further claims have included that the legislation will harm US patients by restricting access to treatments and also further impact pharma companies’ R&D decisions.

Fan concludes, “Given the current lawsuits the pharma industry has already launched against the Biden Administration over the Inflation Reduction Act, it’s unsurprising the new proposed legislation has quickly come under scrutiny from the pharmaceutical industry. The industry will have some relief from the fact that the US House of Representatives is controlled by the Republicans. Many Republicans had voiced opposition to the Inflation Reduction Act last year and the House Democrats will have difficulties passing the legislation through the House. Any successful legislation that builds off from the Inflation Reduction Act could signal further policy changes for US drug pricing.”

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The Central Drugs Standard Control Organisation (CDSCO), along with state licensing authorities, issued show cause notices in 143 cases after risk-based inspections of 162 pharma firms, informed Mansukh Mandaviya, Union Health Minister.

He further informed that stop production orders have been issued in 40 cases, cancellation and suspension of product/section licenses in 66 cases, issuance of warning letter in 21 cases and in one case, an FIR has been lodged and three persons have been arrested as per the provisions of the Drugs Rules, 1945. He divulged this information in a written reply to a question in Rajya Sabha.

The Drugs and Cosmetics Act, 1940 and Rules, 1945 regulates the manufacturing, sale and distribution of drugs in the country.

Source: PTI

Edits by EP News Bureau

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The World Health Organization flagged a batch of contaminated common cold syrup, manufactured by an Indian company on Monday. The agency said the batch of the syrup, branded Cold Out, found in Iraq was manufactured by Fourrts (India) Laboratories for Dabilife Pharma, and had higher than acceptable limit of contaminants diethylene and ethylene glycol.

The batch had 0.25 per cent of diethylene glycol and 2.1 per cent of ethylene glycol, when the acceptable safety limit for both is up to 0.10 per cent, WHO said in its medical product alert.

The agency added the manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product. The companies did not immediately respond to Reuters’ requests for comments outside of business hours.

Source: Reuters

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Marksans has announced that the United State Food and Drug Administration (US FDA) has completed a post-marketing adverse drug experience (PADE) inspection. The inspection closed with two observations.

The inspection was conducted at its Goa, Vema manufacturing facility from July 31, 2023 to August 4, 2023. The inspection included comprehensive scrutiny of practices and procedures for reporting of adverse events of Marksans’ marketed products.

We will submit corrective and preventive action plan (CAPA) to the US FDA in the stipulated time frame.

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Multiple stakeholders have joined hands and want the New Drugs, Cosmetics & Medical Devices Bill to be recalled not only to safeguard the spirit of Prime Minister Narendra Modi’s ‘Make in India’ call but also to keep India’s preparedness intact to deal with any pandemic like situation in the future.   

In a joint plea made by the Indian medical device manufacturers, patient interest groups, users and hospitals to Union Health Minister Dr Mansukh L Mandaviya, they have articulated their concerns and have sought the recall of the Bill in the larger interests of the nation and budding indigenous manufacturers of medical equipment, who are playing a pivotal role in bringing resilience in the country’s MSME sector.    

The letter has been signed by Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices (AiMeD); Jatin Mahajan, Secretary, Admi; Dr Giridhar Gyani, Secretary General, Association of Healthcare Providers India; Manish Sabharwal, Secretary, SDMAI; Vivek Mangalwedhkar, Coordinator, IMA; Sanjiv Rehlan, Chairman, PWMAI; Harvinder Singh, General Secretary, SIDS; Vimal Khemka, Secretary, AISNMA; Hitesh Ostwal, ORAMAI; and Prof Bejon Misra, Founder Director, Patient Safety And Access Initiative of Foundation India.

In the joint letter, they have called for a consultation meeting with a fresh committee under the Chairmanship of ICMR/DST/DBT and key stakeholders for discussing feedback from them and careful consideration of their suggestions before finalizing the draft of the Bill and submitting it to the Parliament.

“An inclusive process will help shape an appropriate Regulatory Policy that needs to impact the Medical Devices sector positively,” said Rajiv Nath, Forum Coordinator, AiMeD, and one of the signatories in the letter dated August 2, 2023, while appreciating the tremendous efforts being made to regulate the drugs and cosmetics sector.

In view of the enormous role of domestic players in ensuring India’s self-reliance in the field of medical devices manufacturing, they have stated that the “Bill may kindly be recalled and collective voices of the entire industry and stakeholders may be heard, especially of the domestic manufacturers and consumer and patient safety groups, who should also be allowed to participate in formulating the regulations which will deeply impact us all, before the Bill is presented to the Honorable Members of the Parliament.”

Talking about the Bill, Dr Girdhar Gyani, Director General, Association of Healthcare Providers India, said that “if the bill is implemented, the Medical Devices Manufacturing sector may face supply chain crisis and effectively lose its ability to meet domestic demand, hence in a wider interest the draft bill needs to be reviewed for its effective implementation.

In the letter, they have reiterated the collective plea of the industry “for the need of a separate Medical Devices Act, different from the one meant for regulation of drugs and the need to treat Regulations and Regulatory Framework of Medical Devices as a separate legislative book from Drugs, as is scientifically the case.”

Prof Bejon Misra, Founder Director, Patient Safety and Access Initiative of Foundation India, pointed to legislations adopted in other progressive countries like Canada, EU, UK, Japan, Brazil, Saudi Arabia, etc., and the NITI Aayog Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, which could act as impactful works of reference to discipline manufacturers.

Seeking the decriminalisation of transgressions without mens rea to avoid discouraging investments in manufacturing of the medical devices, they have further stated that for medical devices the penalties/punishment for manufacturing, import and sale or marketing of unsafe medical devices may kindly be rationalised. The penalty/punishment may be staggered, keeping in view the gravity of the offense, and in proportion to the offence.

Reflecting on the issue, Harvinder Singh, General Secretary, (Surgical Instrument Development Society), said: “Leaders of our country have given repeated assurances for decriminalisation of offences and proposed proportionate punitive action. Legislators should avoid replicating the penalties meant for Drugs Act on to the medical devices sector, which are essentially engineering products. Instead, effective compliance mechanisms in progressive countries may be deployed to discipline manufacturers.”

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Centhaquine, a first-in-class drug developed by Pharmazz India, a majority-owned subsidiary of Pharmazz, has received approval from the US-FDA to enter phase 3 clinical trials in the US and the EU. Pharmazz, a Delaware Corporation based in Illinois, US is a biopharma company focused on discovering, acquiring, developing, and commercialising therapeutics that target critical care medicine.

Pharmazz India obtained marketing authorisation for Lyfaquin (INN: Centhaquine) to manage hypovolemic shock in India in May 2020. Centhaquine citrate, a resuscitative agent for managing hypovolemic shock, was found to be effective without causing arterial constriction or an increase in blood pressure by enhancing the output from the heart. It is a compound that acts via a unique mechanism of action. Since more than half of our blood is pooled on the venous side of circulation and is not supplying oxygen and nutrition to the tissues, centhaquine can divert that blood to the heart and on the arterial side of circulation to increase tissue blood perfusion and increase the supply of oxygen and nutrition to the tissues and hence save organ from failure.

In clinical studies already conducted in India, Centhaquine has been found to be safe and effective in improving blood pressure and reducing mortality having been administered to approximately 6000 patients across 250+ hospitals throughout the country. An ongoing phase IV clinical study has enrolled 139 patients until now across many leading Indian hospitals.

Prof Anil Gulati, Inventor, Chairman, and CEO at Pharmazz, has been the force behind leading the discovery, development, and launch of Lyfaquin. He leads clinical development and commercialization of first-in-class drug products in critical care medicine at Pharmazz. He said, “It is indeed a proud moment for us to have received direct approval for US-FDA approved phase 3 clinical trials in the United States and the European Union. Centhaquine was first synthesised in the early 1970s at the Central Drug Research Institute, Lucknow, India. However, it could not be developed as a drug. Decades later, one of my colleagues, Dr Manish Lavhale, was given the task of conducting a series of experiments, and the findings were so promising that we decided to develop it as a drug for patients going in shock with circulatory failure.”

Dr Manish Lavhale, MD of Pharmazz India, said, “Hypovolemic shock is a serious life-threatening medical condition with about 20 per cent mortality rate. It results from excessive fluid loss leading to inadequate tissue perfusion and oxygenation. Immediate medical attention is required because any delay in therapy can lead to irreversible shock, multi-organ failure, and death. Hypovolemic shock can occur due to haemorrhagic causes (blood loss) or non-haemorrhagic causes (fluid loss). Massive loss of blood or fluids causes a lack of oxygen supply to the tissues leading to failure of multiple organs and death. Agents developed to resuscitate such patients have limited success because most of them improve blood pressure but also cause constriction of the arteries, hence the blood supply to the vital organ does not improve. In such a scenario, Centhaquine is a life saver and also extremely effective as a pre-emptive formulation.”

The compound has already received the Manufacturing and Marketing Authorisation by Indian Regulatory Agency, CDSCO in May 2020. The US FDA directly approved Pharmazz’s phase III IND application and the European Medicine Agency provided its Scientific Advice in November 2022 to assist in the development of Centhaquine for marketing in the European Union. With the completion of this trial, Centhaquine will become a first-in-class new chemical entity that originated from India to become a drug that can be of particular help in saving lives of patients with massive blood loss in civilian or military population.

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Lupin has received the Establishment Inspection Report (EIR) from the US FDA for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms. The EIR was issued post the last inspection of the facility conducted from March 21-29, 2023. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

“We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, MD, Lupin.

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