Last Updated on January 14, 2024 by The Health Master
The Union health ministry has recommended that the requirements of authentic Indian Pharmacopoeia (IP), Indian Pharmacopoeia Reference Standards (IPRS) and impurity standards by the drug manufacturers and testing laboratories should be a part of the ongoing joint inspections planned by the Central Drugs Standard Control Organisation (CDSCO) and the drug regulators in the States and Union Territories (UTs).
The Ministry has also requested the States and UTs to direct the respective State drug regulators to ensure the use of authentic IP, IPRS, and impurity standards to avoid malpractices including presence of spurious drugs in the market.
Rajesh Bhushan, secretary, Union health ministry, in a letter to the state health departments of all states and Union Territories (UTs), said that it has come to the notice of the Ministry that counterfeit copies of the IP and unauthorised Reference Standards are being referred to and used for laboratory work in violation of the provisions of the Drugs and Cosmetics (D&C) Act, 1940.
“Such malpractices may lead to manufacturing and marketing of counterfeit/spurious drugs in India which may lead to hazardous health consequences in the country,” said the secretary.
“I would, therefore, request you to take necessary steps and issue directions to the Drugs Controllers of your States/UTs to ensure the uses of authentic IP, IPRS, and Impurity Standards by the drug manufacturers and testing laboratories under their control,” he added. Details for purchasing IP, IPRS, and Impurity Standards are available on IPC website, he added.
It may be noted that in October last year, Dr Rajeev Singh Raghuvanshi, who was then the head of Indian Pharmacopoeia Commission (IPC) and currently the Drugs Controller General of India (DCGI), in a letter to the then DCGI Dr V G Somani had sought the status of action regarding the implementation of the advice of the Chairman of IPC’s Governing Body in this direction.
The Governing Body IPC has advised the CDSCO to write to the State Regulators to support promotion of IPRS/Impurity Standards and use by stakeholders in their respective states.
IPC said that it is the only supplier of IPRS and Impurity Standards and IPC has not authorised any other party for the distribution. Using unauthorised reference standards is a violation of the provisions of the D&C Act, 1940, he added.
Following the IPC’s letter, on October 10, the then DCGI wrote to the drug controllers of all the States and Union Territories to use the reference standards and impurity standards of IPC as per the regulations, for quality testing of drugs by pharmaceutical manufacturers and testing laboratories in the country.
The IPC functions as an autonomous institute under the Union health ministry in order to fulfill the requirements of the D&C Act, 1940 and Rules, 1945.
The ministry has entrusted the IPC with mandates of publishing the IP at regular intervals along with the certification and distribution of IP RS and Impurity Standards.
An IPRS, being an integral and essential component of the IP Standard, is an official standard that alone is authoritative in assessing the quality of drugs and use of any unauthorised reference standard is a non compliance of the IP Standards.
As per Schedule M of the D&C Act, Part I, Quality Control System, “Pharmacopoeia reference standards, working standards, references, spectra, other reference materials and technical books, as required, shall be available in the Quality Control Laboratory of the licenses”.
IPC has been making efforts to promote the use of authentic copies of the IP, IPRS and Impurity Standards by the manufacturers and testing laboratories, said the ministry.
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