The Uttarakhand Drugs Controller (DC), Tajber Singh has suspended manufacturing licences of around 50 pharmaceutical companies involved in manufacturing of fixed dose combinations (FDCs) without approval from the Drugs Controller General of India (DCGI).
Ambic Aayurchem in Roorkee and Mascot Healthcare in Haridwar were among the 50 FDC manufacturers whose licences were suspended. Over next three months, state DC is likely to suspend manufacturing licences of another 200 drug companies found guilty of violating rules, said Singh who is the Drug Licensing & Controlling Authority, Uttarakhand.
Ambic Aayurchem and Mascot Healthcare involved in manufacturing of FDC of metformin HCL and teneligliptin hydrobromide hydrate, teneligliptin and pioglitazone HCL, pioglitazone, itraconazole and terbinafine HCL without approval from DCGI were raided by CDSCO.
The licences of drug companies were suspended following a report by a two-member panel comprising Gaurav Singh, senior drugs inspector, Haridwar and Neeraj Kumar, drugs inspector, Haridwar which was formed by the state Drugs Controller following a raid by CDSCO last month.
The panel's term of reference was to examine each and every product approval given to the manufacturers in the state and to submit a report on FDCs which have not been approved by DCGI.
The panel in its report to Uttarakhand Drugs Controller pointed out that around 250 drug companies lacked DCGI approval to manufacture FDCs in the state.
However, manufacturers said though the FDCs manufactured by them were not approved by central drug licensing authority, they were approved by other state licensing authorities.
It is learnt that the manufacturers are planning to approach court challenging Uttarakhand Drugs Controller's suspension order.
In this connection it is pertinent to mention that combination of two or more drugs i.e. FDC combined for the first time fall under the definition of new drug. The requirements for import, manufacture of new drugs including FDCs were introduced to Drugs and Cosmetics Rules, 1945. Permission from the office of DCGI is required before these are licensed by state licensing authorities (SLAs) for manufacture, sale in the country.
Acting on the committee report, Uttarakhand Drugs Controller office had started inspection of plants for product approval and suspended licences of at least 50 manufacturers lacking DGCI permission so far.
Earlier Uttarakhand DC had suspended manufacture, sale or distribution of FDC drugs approved by it following the crackdown by CDSCO.