The year 2023 marks new advancements in innovations and technology in the field of the pharma industry. Its progress is seen not only in India but all over the world. Approval of new drugs, adoption of new therapies for the treatment of diseases, and inclusion of policies in every aspect of the pharma field are remarkable.
The phenomenal changes in the pharma domain that happened in every month of the year 2023 are here:
January 2023:-
AstraZeneca's Airsupra received FDA approval in January 2023, marking a significant milestone in offering an effective and innovative treatment option for asthma patients worldwide.
February 2023:-
Clarivate's Drugs to Watch report identifies 15 potential blockbuster drugs expected to generate over $1 billion in annual sales within five years.
These treatments span various conditions, from Alzheimer's and Parkinson's to HIV, cancer, and chronic kidney disease.
Noteworthy candidates include Lecanemab and Bimekizumab for psoriasis, Capivasertib for breast cancer, and Daprodustat for CKD-related anemia.
Breakthroughs like Lenacapavir for multidrug-resistant HIV and Teplizumab for type 1 diabetes offer significant advancements. Anticipated launches in 2023 for Parkinson's, hemophilia A, and plaque psoriasis underscore the transformative potential of these medications in revolutionizing patient care.
March 2023:-
The government canceled the licenses of 18 pharmaceutical firms due to their involvement in producing counterfeit or spurious medicines. This action came after a thorough inspection conducted by the Drugs Controller General of India (DCGI) across 76 companies in 20 states, revealing irregularities that led to the cancellation of these companies' licenses for manufacturing medicines.
April 2023:-
Health Minister Mansukh Mandaviya announced a notable reduction in the prices of 651 essential drugs by an average of 6.73% effective from April 1. He highlighted the efforts of the National Pharmaceutical Pricing Authority (NPPA), which successfully established the ceiling prices for 651 medications among the over 870 scheduled drugs listed under the National List of Essential Medicines (NLEM).
May 2023:-
Union Chemicals and Fertilizers Minister Mansukh Mandaviya declared the government intends to bring a product-linked incentive (PLI) scheme for the development of basic chemicals that are needed in the agrochemicals, petrochemicals, and pharma-active pharmaceutical industries. While addressing an international conference on the pharma and medical devices sector, he emphasized that India is the “pharmacy of the world” and the industry is required to concentrate on research and innovations to maintain its leadership status.
He also launched a scheme named the ‘Assistance to Medical Devices for Common Facilities (AMD-CF) scheme to strengthen the existing pharmaceutical clusters’ capacity for sustained growth by creating common facilities. The minister released the National Medical Devices Policy 2023, along with its strategy document, and launched the Medical Devices Export Promotion Council.
June 2023:-
The Indian government has banned fourteen fixed-dose combination drugs, as such combinations have no therapeutic justification and these medicines may involve risks to people. The notification is issued by the Union Health Ministry.
The banned drug combinations are Nimesulide + Paracetamol dispersible tablets, Chlorpheniramine Maleate + Codeine Syrup, Pholcodine + Promethazine, Amoxicillin + Bromhexine, and Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol, Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin, and Salbutamol + Bromhexine.
July 2023:-
The Indian government held discussions with the Netherlands government to enhance their bilateral trade in the pharmaceutical sector. Meetings were organized with officials in pharmaceutical affairs, medical technology, and the Ministry of Health, Welfare, and Sports.
During the discussions, both countries focused on issues related to the equity and affordability of pharmaceutical products, the supply chain for vaccine raw materials, and cross-border investment.
August 2023:-
The Food and Drug Administration (FDA) vested authorization for the drug named Zurzuvae to treat postpartum depression, which is a condition impacting thousands of mothers in the US every year. Based on the clinical trial data, it shows that, compared to general anti-depressants, this pill works quicker, easing depression in three days.
This made more women move forward to strive for help to treat their symptoms and reduce the stigma around postpartum depression.
September 2023:-
On September 26–27, 2023, the FDA/PQRI hosted a public workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing, which was designed to provide another opportunity for all stakeholders to discuss key topics with regulators, such as:
AI in Process Development, Process Monitoring, and Commercial Batch Trend Monitoring
AI and the Use of Big Data and Data Management within the Pharmaceutical Quality System
Lifecycle Approaches to the Management of AI
October:-
CDSCO released the report for syrups used in cough and allergic rhinitis by two Indian manufacturers that have been found to contain higher than permissible levels of contaminants: diethylene glycol (DEG) and ethylene glycol (EG). The World Health Organization (WHO) also issued alerts on contamination in cold-cough syrups exported by India and said these two contaminants were found in the drug. This comes after the deaths of 141 children worldwide.
November 2023:
On November 30, 2023, the Indian Pharmacopoeia Commission (IPC) issued an alert that consumers and healthcare professionals should closely monitor the possibility of adverse drug reactions associated with the painkiller Meftal. It also said that if such a reaction is encountered, the alert advises that people should report the matter to the national coordination center of the PvPI on www.ipc.gov.in or through the Android mobile app ADR PvPI and PvPI Helpline No. 1800-180-3024.
December:
On December 18, 2023, the Central Drugs Standard Control Organization (CDSCO) banned the use of an anti-cold fixed drug combination for children under the age of 4. This popular anti-cold fixed drug combination (FDC) contains two drugs, chlorpheniramine maleate and phenylephrine.
References:
https://www.outsourcing-pharma.com/Article/2023/01/13/asthma-treatment-approved-by-fda-after-positive-trial-results
https://www.drugtopics.com/view/drugs-to-watch-15-potential-blockbuster-drugs-in-2023
https://m.timesofindia.com/india/govt-cancels-licenses-of-18-pharma-companies-for-manufacturing-spurious-medicines/articleshow/99065488.cms
https://www.thehindu.com/news/national/price-of-651-essential-drugs-has-come-down-by-673-from-april-1-mansukh-mandaviya/article66695523.ece
https://www.thehindu.com/business/govt-plans-pli-scheme-for-basic-chemicals-used-in-pharma-other-industries-mandaviya/article66898014.ece
https://www.indiatoday.in/india/story/government-bans-14-fixed-dose-combination-drugs-citing-risk-to-people-2388456-2023-06-03
https://www.livemint.com/news/india/india-in-talks-with-netherlands-to-strengthen-vaccine-raw-material-supply-chain-and-pharmaceutical-trade/amp-11689184144016.htm
https://www.nytimes.com/2023/08/04/health/postpartum-depression-pill-fda.html
https://www.fda.gov/drugs/fdapqri-workshop-regulatory-framework-utilization-artificial-intelligence-pharmaceutical (Visited on 29/12/2023)
https://www.thehindu.com/sci-tech/health/batches-of-india-manufactured-syrups-for-cough-allergic-rhinitis-found-contaminated-cdsco/article67381808.ece
https://www.medboundtimes.com/medbound-blog/attention-popular-anti-cold-fixed-drug-combination-banned-for-children-under-4-years
https://www.medboundtimes.com/medicine/ipc-alert-painkiller-meftal-can-have-adverse-reactions
(Input from various media sources)
(Original/Lavanya Beeraboina/Jeba Mulani/Komal Bhoi)