Pharmaceutical Updates – September/October 2022

Update 1: Gambia Deaths: Govt panel conducted the first meeting and is expecting more documents from WHO

As we know, the Haryana health authorities have paused all pharmaceutical manufacturing at Sonipat-based Maiden pharmaceuticals because of deficiencies found during a joint inspection by the central drug regulatory authority and Food and Drug Administration (FDA), Haryana. The technical experts have united to make a union health ministry to analyze and understand the disastrous scenario reports, causal relationship, and related details, as the World Health Organisation guided by the cough syrup fiasco in the Gambia. In their first official group conversation, the committee members sincerely analyzed the available documents. “Some facts and information, including the notice by the WHO and the documents available in the public domain so far, have been studied in detail. However, there are more documents from the WHO to understand more about the incident.

 Whether the cough syrups made by local manufacturer Maiden Pharmaceutical were the actual cause of the deaths of children or precipitated into the same, time and analysis is the only solution to understand the reason for the scenario. The committee will also state the Drugs Controller General of India (DCGI) regarding the advanced course of action. Stay tuned for more updates. 

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Update 2: Syngene set for the phase-2 trial of Covid oral tablet vaccine

Vaxart initiated the trials of its oral recombinant tablet vaccine in October last year. It enrolled 96 participants from untreated and previously vaccinated patients at four centers in the US.

Now, decks have permission for Bengaluru-based Syngene International to start a phase II clinical trial for the oral Covid-19 vaccine in India. Central Drugs Laboratory (CDL), Kasauli, has successfully passed the batches of the tablet vaccine Syngene imported from an American biotechnology company, Vaxart.

 Samples of -VXA-CoV2 Enteric-coated pharmaceutical tablets manufactured by Vaxart have been passed by the laboratory at CDL Kasauli. The trial has won with the relevant solutions for the safety, efficacy, and immunogenicity of an adenoviral-vector-based tablet vaccine against Covid-19. The company has planned to commence a global, placebo-controlled efficacy trial recruiting more subjects. Vaxart will now broadcast the advanced medicines of oral tablet vaccine administration trials at the World Vaccine Congress Europe 2022 in Barcelona, Spain.

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Update 3: QR codes will be a new trend to keep track on top medicine brands

Approximately 300 top-selling drugs will now necessary should have a printed QR code on the ‘primary’ packaging labels in accordance with the government’s plans of launching a ‘track and trace’ mechanism, a Times of India report cited sources as saying. This is done to check the circulation of counterfeit drugs and ensure the traceability of the essential medicine brands. These medicines may include the category of antibiotics, pain-relief pills, cardiac, and anti-allergics and shall soon come under the ambit of the new system.  

 About 10% of pharmaceutical products in low- and middle-income or underdeveloped nations are substandard or falsified. However, these could be found in anywhere around the world, the Times of India report quoted from World Health Organisation records and statistics. Implementing this process will raise the prices by 3-4% in pharmacies.

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Update 4: Committee to give a statement in the next 90 days regarding the regulation of the marketing practices of pharma companies

The government has formed a committee, including a high-level committee, to bring in a legal system to acknowledge and speak about the challenges of pharmaceutical companies giving suggestions and inducements for promoting their drugs and products. The chairperson of the committee, Dr. VK Paul, NITI Aayog member (health), will also give his thoughts on the challenges and understanding in detail, the uniformity in Pharmaceutical Marketing Practices. 

 An office memorandum proposed on September 12, 2022, says that the department of pharmaceuticals holds a place of ethics, the UCPMP, for the pharma industry, which is working effectively since January 1, 2015, and has successfully adopted all the significant pharmaceutical associations. The code will help the procedure of filing complaints, inquiries penal actions, etc., appropriately done by the pharma companies which are a member.

 The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, under the Indian Medical Council Act, 1956, as changes from time to time according to the requirements of the pharma companies, mentioned in detail the relationship of the healthcare professionals with pharmaceutical companies and prohibits the physicians and medical practitioners from committing such acts which are “unethical” in nature, the office memorandum stated.

 “Hence, to understand and acknowledge the issue holistically and align the problems by various stakeholder departments and also to analyze all the challenges on the requirement of legally enforceable mechanism for regulating marketing practices, a High-Level Committee is constituted,” the memorandum said.

This committee is made to examine and give proper solutions to the provisions of stakeholder departments on pharmaceutical marketing practices and their practical implementation. The committee will stand and give its statement on this within 90 days.

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