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Nikhil Prasad  Fact checked by:Thailand Medical News Team Dec 31, 2023  1 month, 3 weeks, 6 hours, 35 minutes ago

BREAKING Pharma News! European Medicines Agency Suspends More Than 400 Generic Drugs From India Over Flawed And Possible Fraudulent Studies In Pune!

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BREAKING Pharma News! European Medicines Agency Suspends More Than 400 Generic Drugs From India Over Flawed And Possible Fraudulent Studies In Pune!
Nikhil Prasad  Fact checked by:Thailand Medical News Team Dec 31, 2023  1 month, 3 weeks, 6 hours, 35 minutes ago
Pharma News: India is a country where doctors and researchers can be easily bought for small sums of monies to manipulate studies and officials at regulatory agencies in India can be easily bribed to issue relevant drug and supplement approvals or licenses despite ‘half-baked’ supporting data. Worse, the various companies in India that are known to manufacture various generic drugs, supplements including food supplements often cut corners and use cheap adulterated ingredients that are often contaminated with dangerous compounds not to mention the low-quality control and unhygienic conditions in these manufacturing plants.

Drug Recalls Involving Generic Medications From India - A Common Occurrence
Every year, on numerous occasions we can hear of drug recalls in the United States, Canada, Australia and Europe over substandard generic drugs from India, in some cases even causing serious conditions and even deaths. The recent being cough and NSAID syrups for pediatric use from India that caused the deaths of children in many countries and also the eye drops from India that caused blindness in many in the USA.
Generic Drugs From India Found To Lack Proper Bioactivity
Trending Pharma News coverages across Europe has highlighted that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has proposed the suspension of marketing authorizations for nearly 4 00 generic medicines due to flawed studies conducted at in Synapse Labs, a laboratory India.
The EMA revealed that irregularities in study data and various inadequacies have cast doubt on the validity and reliability of data from studies carried out at a lab in Pune, India called Synapse Labs Pvt Ltd.
It was reported that the managing director of Synapse Labs, Vishal Dhawan (a Punjabi)  did not respond to any media queries on the latest development involving his company.
Initiated at the request of the Spanish Agency of Medicines and Medical Devices, the review by CHMP encompassed generic medicines undergoing evaluation or already authorized through national, decentralized, or mutual recognition processes. The EMA highlighted findings of non-compliance with good clinical practice at Synapse Labs in Pune, India. The CHMP identified discrepancies in study data, deficiencies in study documentation, as well as issues with computer systems and procedures for managing study data at the laboratory.
In a statement released on December 15, 2023, the EMA expressed serious concerns about the reliability and validity of data from bioequivalence studies conducted at Synapse Labs. These studies aimed to demonstrate that the generic medicines released the same amount of active substance in the body as the reference medicine.
The review considered all available information, including additional bioequivalence data. For approximately 35 of the medicines, the EMA found "sufficient supporting data" demonstrating bioequivalence, allowing the maintenance of marketing authorizations and ongoing marketing applications.
However, for the remaining medicines on the list, supporting data were deemed "lacking or insufficient to show bioequivalence," leading to the CHMP recommending the suspension of their marketing authorizations.
To lift the suspension, companies must provide "alternative data demonstrating bioequivalence." Additionally, medicines with ongoing marketing authorization applications relying solely on data from Synapse Labs will not be granted authorization in the EU.
The EMA cautioned that some of the medicines recommended for suspension may be of critical importance, and national authorities can postpone the suspension for a maximum of two years in the interest of patients. However, companies must submit the required bioequivalence data within one year.
The EMA announced that the CHMP's recommendation will be forwarded to the European Commission, which will issue a legally binding decision applicable in all EU member states. Julian Beach, interim executive director of healthcare quality and access at the Medicines and Healthcare products Regulatory Agency, emphasized collaboration within the UK health system and international regulators and pledged regulatory action if necessary, particularly for medicines critical to patients.
The U.S. FDA should also take note of this latest development along with drug regulatory agencies across the world and react accordingly.

Time To Ban Indian Drugs And Supplements
It is time for countries around the world to ban all medications and drugs from countries like India, Bangladesh, Pakistan and China and to start being self-reliant and start investing in generic drug manufacturing plants in their own countries including the manufacture of necessary APIs (Active Pharmaceutical Ingredients.)
Without wanting to sound racist as I am an of ethnic Indian origin myself but hailing from Singapore and Australia, most of these Indians from India and countries like Thailand or Myanmar involved in healthcare and pharmaceuticals etc are simply despicable and have no ethics and have no regard for human life and are not much different from the greedy Chinese or the scammers from Pakistan!
Europe, Canada, United States, Japan, South America, Australia, New Zealand Africa and the rest of Asia should ban all drugs and supplements from India and also supplements made by ethnic Indians in South-East Asia, Bangladesh and South America.
Thailand Medical News is currently working with a team of American and Japanese researchers to uncover possible scams involved in a supplement brand that originates from a country in South-East Asia with local Indians involved behind the brand.
It is also best to avoid any medical products made by Indians especially by Punjabis as most are scammers as I myself have personally had so many such bad encounters by many such individuals in Thailand, Indonesia, United States and Australia.
For 2024, there are some groups working anonymously to creates sites online that will list businesses owned by Punjabis and also companies that employ Punjabis in key positions in major countries in South East Asia that should be avoided and also include the scams or crimes that some individuals or companies have been involved in.
For the latest Pharma News, keep on logging to Thailand Medical News.


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