IPC Starts Verifying Testing Protocols For DCGI Approved Drugs


Mumbai : The Indian Pharmacopoeia Commission (IPC) has started verifying the testing protocols for Drugs Controller General of India (DCGI) approved drugs recently introduced in the Indian market.

With reference to the testing protocols, a total 510 of new drug samples (NDS) were received from the office of DCGI for verification during the financial year 2019-20 and report for the same has been successfully submitted. Besides this, out of analysis of 2,141 drug samples, 94 were candidate reference material of Indian Pharmacopoeia Reference Substances (IPRS), 510 were NDS and 1,537 were miscellaneous samples.

Ghaziabad-based IPC provides IPRS which act as a fingerprint for the identification of an article under test and its purity as prescribed in Indian Pharmacopoeia (IP).

A total of 1,537 miscellaneous samples received from the Central Drugs Standard Control Organisation (CDSCO), Central Medical Services Society (CMSS) and Inter Laboratory Comparison (ILC) at IPC for the analysis and reports of the same were successfully submitted to the respective offices.

Several representations were made for the test protocols to be made available for drug testing laboratories/ regulators of the respective states on demand. Indian pharmacopoeia laboratory has also conducted the testing of new drug molecules received from DCGI office and prepared the protocol bank. The protocols are available on demand.

The financial year 2019-20 was a productive year for the IPC to keep abreast the stakeholders of new scientific developments in the area of setting standards of drugs, promoting rational use of medicinal products through generic approach and to ensure patient safety, their rights and well being through Pharmacovigilance Programme of India (PvPI) and Meteriovigilance Programme of India (MvPI).

During crisis of Covid-19 pandemic, to strengthen the quality of drugs in India, union health ministry released the IP Addendum 2019 to IP 2018 on July 5, 2019 at Nirman Bhawan, New Delhi. The IP Addendum 2019 contains 66 new monographs including those of chemicals category (N=61), herbs and herbal products (N=3), and radiopharmaceuticals preparations (N=2). It became official from January 1, 2020.

Further, IPC has drafted a total of 64 new monographs for the Addendum 2021 to IP 2018 including 57 chemical monographs, 2 blood and blood related products monographs, 5 herbs and herbal products monograph and 7 general chapters. IP has been recognized formally by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Islamic Republic of Afghanistan and also will be used based on the requirement as reputable pharmacopoeia in the laboratory of medicines and health products quality.

Afghanistan has become the first country to recognize the IP, pursuant to the efforts of the union health ministry and the Union commerce ministry of commerce.

A total number of 94 Reference Standards have been developed during the index period of 2019-20. This includes 13 IPRS, 21 Impurities, and 60 IPRS lot replacements.

Till date, a total of 598 IPRS and 154 Impurity Standards have been developed by the IPC and comprehensive list is available on the website of IPC (www.ipc.gov.in). In addition, a total of 489 numbers of IPRS were retested for their potency and stability.

Also, a total of 211 new candidate materials were received from stakeholders and processed to develop new IPRS. A total of 81 candidate materials are under validation to develop as IPRS and Impurity Standards.


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