New Delhi: The Drugs Controller General (India) (DCGI) has informed all state drug regulators that the Central regulatory authority has not approved manufacturing and marketing of antibiotic combination of meropenem 1 mg and EDTA for injection and it is against the rules to produce and sell the drug without its approval.
The drug regulator said that it has come to its notice that some manufacturers are involved in manufacturing and marketing the combination, which is not yet approved by the Central Drugs Standard Control Organisation (CDSCO) for manufacturing or marketing in the country and falls under the category of new drug.
DCGI Dr Rajeev Singh Raghuvanshi in a notice to all the concerned stakeholders said, “No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019”.
Further, as per Rule 80 of New Drugs and Clinical Trial Rules, 2019, a person who intends to manufacture new drug in the form of active pharmaceutical ingredient (API) or Pharmaceutical formulation, as the case may be for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule.
It may be noted that last month, the DCGI has directed the state drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also.
The DCGI during the time said that it has come to the notice of the CDSCO that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug.
“…you are hereby directed to convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug,” said the DCGI. The necessary information about the status and action taken in the matter may be intimated to the CDSCO at the earliest, he added.
According to the online trading portals, the drug combination meropenem and disodium EDTA for injection is sold by a manufacturer as an ultra broad spectrum antibiotic and claimed as effective and well-tolerated for the treatment of infections including bacterial meningitis, lower respiratory tract infections and used in treatment of certain types of cancer.
It may be noted that this is not the first time the national drug regulator takes up the issue of drug combinations and new drugs getting manufactured and marketed in the country without its approval, using the license issued by the state or UT drug regulators. Regulatory experts point towards the issues in proper communication between the regional and central drug regulatory mechanism, among others, as a reason for such mistakes.
The Drugs Technical Advisory Board (DTAB) has recently suggested the Drugs Consultative Committee (DCC) to collect opinion from the States in the upcoming meetings on having a single licensing or approval authority in the country.
The discussions for a centralised drug regulatory mechanism has been discussed in the past, especially after the incidents where the Indian made medicines such as cough syrups reportedly had an adverse impact and resulted in the death of many children overseas.
The drug regulatory experts also suggested that there should be a single national portal where the State drug regulators could update the status of a drug license and quality test results, so that the information would be available to the national drug regulator for any reference.
It may be noted that a national effort to take action against irrational fixed dose combinations in the country earlier has brought out the information that several FDCs were approved by the state or UT regulatory authorities without the approval of the Central drug regulator.
