The manufacturers of active pharma ingredients (API) will require a no-objection certificate (NOC) from the Central Drugs Standard Control Organisation (CDSCO) for supplying the bulk drug for a particular formulation which is meant for export, as in the case of the producer of the formulation.
According to a notice by the CDSCO, it has also laid down detailed procedure for seeking the NOC and submitting the legal undertaking if the bulk drug is to be obtained from another manufacturer, other than the producer of the formulation for export.
“For manufacturer of unapproved or approved new drug or prohibited drugs for export, NOC is granted by CDSCO on case-by-case basis against valid export order. The issue of manufacture of such drug for export by the manufacturer of drug formulation after obtaining the API from other bulk drug manufacturer in our country has been examine by the office of the DCGI in consultation with the Ministry of Health and Family Welfare. It has been decided that along with NOC to the formulation manufacturer for export of its drug formulation, an NOC to the API manufacturer of the said bulk drug required for manufacture of formulation may also be granted to the API manufacturer for manufacturing the specific quantity of API for sole supply to the formulator,” said the notice.
According to the procedure, the formulation manufacturer should apply for NOC to the CDSCO zonal office along with the purchase order and quantity required. The applicant will also be required to submit legal undertaking in the prescribed format from bulk API manufacturer. Based on the application and the legal undertaking submitted by the applicant, an NOC would be issued, said the notice.
“The manufacturing site/unit of formulation manufacturer will be regularly checked by drug inspectors/ADC (I)s to verify that API and formulation of the unapproved drugs are not diverted for sale in the country,” the directive said.
“It may kindly be seen that both the manufacturers of such API/bulk drugs and the manufacturers of the formulations who would use such bulk drugs would be required to furnish legal understandings in this regard. In the event of non-materialization of export for some reason, the same would be intimated to the state licensing authorities concerned and the manufacturers shall ensure physical destruction of such drugs in the presence of state licensing authorities,” it said.