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Industry urges govt to share IPRS & impurity standards free of cost to MSMEs
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Gireesh Babu, New Delhi
October 13 , 2022
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Even as the drug regulator of the country has called for the State drug regulators to ensure use of Indian Pharmacopoeia Reference Standards (IPRS) and impurity standards by the pharmaceutical manufacturers and testing laboratories, the industry demanded that the government should share the reference standards free of cost to the micro, small and medium enterprises (MSMEs) as the current prices are not affordable to the units.
The Central Drugs Standard Control Organisation (CDSCO) has issued a letter to all State and Union Territory Drugs Controllers on October 10, to ensure use of IPRS and Impurity Standards by the pharma manufacturers and testing laboratories for quality testing of drugs, as per the Drugs and Cosmetics Act, 1940 and Rules thereunder.
The directive followed an Indian Pharmacopoeia Commission’s (IPC) letter seeking the Drugs Controller General (India) to write to the state regulators to support promotion of IPRS and Impurity Standards and update the status of action in the 22nd meeting of the Government Body of IPC scheduled for October 14, 2022.
The Government Body, in its 21st meeting on April 26, 2022, advised the DCGI to communicate to the State regulators regarding the use of the standards and the DCGI in March, requested the same to the State drug regulators.
“For a normal unit to buy reference standards, it would cost a minimum of Rs 10 lakh. It could be more also since many units manufacture 100-200 products or more,” said Jagdeep Singh, Secretary General, SME Pharma Industries Confederation (SPIC). “The prices are prohibitive,” he added.
Such a burden cannot be borne because there is too much competition. Proliferation of the pharma industry from 2005 to 2010 in Tax Holiday states ushered this cut throat competition between pharma units which is the cause of the malaise. Tax Holiday was given by NDA in 2003 but MRP Excise was levied by the then Finance Minister P Chidambaram in 2005 without consulting the concerned Ministries.
High excise burden caused by anomalies in MRP excise was the reason why industry proliferated in Tax Holiday States which made pharma industry unviable. Cut throat competition is responsible for the ills today.
“There is not a single unit which can afford to keep up with the directives unless the market is cleansed of low priced drugs by the drug department which is not easy because of corruption and extortion prevailing all over the country,” he averred.
“The government can supply these standards free of cost or at nominal cost, to ensure quality standards. There is no justification for such exorbitant prices for reference standards. Why should IP cost Rs. 60,000 and one impurity standard cost Rs. 20,000?,” asked Singh.
In order to ensure quality, the government should intensely regulate bulk drugs and other raw materials. While there have been regulations and amendments to regulate the formulations industry, there is no control over the quality of bulk drugs.
Another solution is that the lowest priced drugs in the market should be sampled, since they are the ones which are cutting corners on quality, he added.
IPC has recently announced that it has achieved the milestone of developing a total of 1000 IPRs and Impurity Standards, with around 660 IPRS and 345 Impurity Standards listed in the IPC catalogue. It has also come out with the publication of the ninth edition of IP 2022 which will be effective from December 1, 2022.
IPC, in its letter to the DCGI, said that it is also making efforts to promote the use of authentic copies of IP 2022 along with IPRS and Impurity Standards by the Pharmaceutical Manufacturers and Drug Testing Laboratories for which awareness programmes for stakeholders are being organised across the country. It added that IPC is the only supplier of IPRS and Impurity Standards and it has not authorised any other party for their distribution.
“Using unauthorised reference standards is a violation of provisions of the Drugs and Cosmetics Act, 1940,” added the IPC.
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