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To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is honey almond crunch. Can you guess what gives it the crunch? Meanwhile, the time has come to get cracking. Here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. Feedback, tips, and suggestions are always welcome. …

The U.S. Food and Drug Administration is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions align with the agency’s national health priorities, STAT tells us. Those priorities include addressing unmet public health needs or health crises, beefing up domestic production of drugs, and delivering more innovative cures. The new priority review relies on a carrot instead of a stick. Rather than the typical review time of 10-12 months, recipients of the “Commissioner’s National Priority Voucher” are entitled to a review within one to two months after a final drug application is submitted. A “limited” number of companies will receive the vouchers this year. Some may also earn an accelerated approval, in which the FDA sends a drug to market based on an endpoint predicting clinical benefit. Chosen companies will also be subject to a different regulatory process. An application will be reviewed not by scientists in a specific FDA center, but by a “multidisciplinary team” of physicians and scientists across the agency. 

Dozens of companies have pledged to build  more manufacturing facilities in the U.S. since President Trump took office, but generic drugmakers are not among them – and they have no plans to change that anytime soon, The Wall Street Journal notes. Generic drug companies – which supply about 90% of the medications taken by Americans – say further domestic investment is too risky in such a low-margin and unpredictable business, unless the government helps to steady the sector. Drugmakers want more clarity from the Trump administration on the potential pharmaceutical tariffs, which some companies warn could lead them to close U.S. plants altogether. More U.S. investment by brand-name drugmakers, however, will not address issues such as curbing shortages of drugs or supplying essential medicines, which largely involve generic drugs that are made overseas, according to supply-chain experts. Instead it will spur production of expensive medicines already made in America such as cell therapies or biologic cancer drugs, which make up more than 80% of the country’s drug expenditure.

Continue to STAT+ to read the full story…

WHEN ANAKAY Montaque, 59, speaks about the power of blood, she is not referring to faith alone. She is talking about the literal, lifesaving kind, the type selflessly donated by strangers, coursing through her veins and giving her a second chance...

Strengthening cooperation and exchange with BRICS countries key to advance priority health commitments, PAHO Director says

Cristina Mitchell

17 Jun 2025

The lawmakers accuse Pfizer, Merck, J&J, AbbVie and Amgen of paying little to nothing in federal taxes despite generating billions of dollars annually.

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This was stated by Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers, Anupriya Patel at the inaugural session of the Second Policymakers’ Forum organised by Indian Pharmacopoeia Commission (IPC).

She further emphasized that “during the COVID-19 pandemic, India started the Vaccine Maitri initiative and supplied vaccines to more than 100 friendly countries which depicts India’s deep sense of responsibility towards global health and its intention of helping friendly countries in the times of distress.”

The Second Policymakers’ Forum, aimed at promoting recognition of the Indian Pharmacopoeia and collaboration in India’s flagship affordable medicines initiative—the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), is being organized by the IPC under the aegis of the Ministry of Health and Family Welfare, in association with the Ministry of External Affairs.

In her keynote address, Smt. Patel emphasized India’s commitment to ensuring equitable access to quality-assured medicines and stressed the importance of regulatory harmonization in facilitating global health equity. She also highlighted that “under the visionary leadership of Prime Minister Shri Narendra Modi, India has emerged as a global hub for affordable healthcare solutions and continues to deepen its partnerships with nations through knowledge-sharing, capacity-building, and health diplomacy.”

Underlining the importance of the Jan Aushadi Kendras, Smt. Patel stated that “our Jan Aushadhi Kendras are the shining examples of India’s commitment to provide quality and affordable medicines to all our citizens. Jan Aushadhi has been one of the most powerful instruments of bringing down the out-of-pocket expenditure of our citizens.”

Smt. Patel also added that “India continues to be a leader in drug manufacturing, especially when it comes to the generic medicines. 14% of generics imported by the US come from India while India also has the maximum number of US FDA (Food and Drug Administration) recognized drug manufacturing plants.” She further underlined that “70% of our generics are exported to the highly regulated markets and our pharmacopeial regulations are regularly visited to meet the global benchmarks.”

Smt. Patel further stated that “we have retained the WHO’s Global Benchmarking Tool (GBT) framework, Maturity Level 3 (ML3) status which reflects the robustness of India's regulatory framework. Presently, 15 countries in the world recognise Indian Pharmacopeia as a book of standards for drugs, Cuba recently becoming the 15th country to recognise the Indian Pharmacopeia.” She added that “it is not just a regulatory step, but a move towards bringing more alignment in the quality standards, expanding access to safe and effective drugs and making trade in pharmaceuticals smoother than ever before.”

Smt. Patel reaffirmed that “we are committed to helping our partner countries by way of communicating and planning” and “hope to continue to work together to advance the regulatory collaboration and promote the recognition of the pharmacopeial standards so that we can strive fast towards the shared goal of ‘Health for All’.”

Addressing the gathering, Union Health Secretary, Smt. Punya Salila Srivastava stated that “India subscribes to the vision of "One Earth, One Health " and is committed towards goal of universal health coverage which is also one of our primary health goals. To fulfil this, we have established more than 1.75 lakh Ayushman Arogya Mandirs (formerly known as Health and Wellness Centres) where free drugs and diagnostics are provided.” She also talked about India’s health assurance scheme, Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) that provides a health coverage of up to 5 lakhs per family and caters to the 40% population of the country and highlighted that “in 2004, the share of out-of-pocket expenditure in total health expenditure was 70%, which has come down to 40% today.”

Health Secretary further underlined that the increased availability of free drugs and diagnostics has been enabled by the production of generic medicines, noting that the number of free medicines provided at sub-health centres has risen from 36 to 106 over the past decade. She emphasized the role of AMRIT pharmacies in offering affordable branded medicines and medical devices, and noted that the forum will serve as a platform for bilateral cooperation, knowledge sharing, and future collaboration.

An international delegation of policymakers and drug regulators from 24 countries is participating in the forum. The event was also attended by Secretary, Ministry of Health and Family Welfare, Smt. Punya Salila Srivastava; Secretary (South), Ministry of External Affairs, Dr. Neena Malhotra; Drug Controller General of India and Secretary-cum-Scientific Director, IPC, Dr. Rajeev Singh Raghuvansi.

The Forum has brought together policymakers and senior drug regulatory officials from 22 countries (Liberia, Togo, Mali, Mauritania, Sierra Leone, Cameroon, Rwanda, Lesotho, Eswatini, Kenya, Botswana, Ethiopia, Comoros, Seychelles, Madagascar, Papua New Guinea, Zimbabwe, St. Lucia, St. Vincent & Grenadines, Cuba, Barbados, and Chile), along with two delegates from the Caribbean Public Health Agency (CARPHA)- Jamica and Canada, reaffirming India’s position as a valued and trusted partner in the realm of global health. This engagement builds on the momentum generated by the First Policymakers’ Forum held in August 2024, which resulted in several participating countries formally recognizing the Indian Pharmacopoeia as a book of standards for drugs. The growing international interest in aligning with India’s regulatory frameworks reflects the credibility and scientific rigour of the Indian Pharmacopoeia, as well as India’s proactive role in advancing global public health objectives.

A commemorative digital publication marking IPC’s 15-year journey was launched during the event. The technical session featured presentations on the role and progress of the Indian Pharmacopoeia Commission (IPC), the regulatory mechanisms of the Central Drugs Standard Control Organization (CDSCO), and the implementation and impact of the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP).

Over the four-day program (June 16–19, 2025), delegates will engage in technical sessions focused on pharmacopeial standards, India’s regulatory landscape, and successful public health schemes. In addition, site visits to IPC’s state-of-the-art laboratories in Ghaziabad, a Jan Aushadhi Kendra in Agra, as well as leading pharmaceutical and vaccine manufacturing and R&D facilities in Ahmedabad, have been arranged to provide delegates with first-hand exposure to India's robust scientific and regulatory systems.

Shri Rajiv Wadhawan, Advisor (Cost), Ministry of Health & Family Welfare; Dr. Ranga Chandrasekhar, Joint Drugs Controller; and Shri Ravi Dadhich, CEO of the Pharmaceuticals & Medical Devices Bureau of India and senior officers of the union government were present on the occasion.

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just ophthalmologists but family doctors, gynecologists, endocrinologists, oncologists and all other health care professionals involved in women’s