Technical flaws at pharma units invited ire of regulatory bodies
Ambika Sharma
Solan, June 21
Two phases of joint risk-based inspections by the state Drugs Control Administration (DCA) and the Central Drug Standards Control Organisation (CDSCO) found non-functional air handling units, dysfunctional lab equipment in micro-labs and absence of proper maintenance of machinery, besides other laxities at various pharmaceutical units.
51 of 71 shortlisted units inspected
- State and central drug regulatory bodies conducted joint inspections of pharma units in two phases
- 51 of the 71 shortlisted drug manufacturing units were inspected during December-February and March-May
- Of these, 26 faced show-cause notices, 11 stop-production orders, while two units are facing licence
- cancellation
- The state houses 665 pharmaceutical units; every third drug in the domestic market is manufactured in Himachal Pradesh
Schedule M of the good manufacturing practices (GMP) under the Drugs and Cosmetics Act, 1940, is supposed to be followed by the pharmaceutical units in the country, besides the good laboratory practices. Adherence to these norms ensures quality, safety and reliability of the drugs produced.
In the two phases, 51 of the 71 shortlisted drug manufacturing units were inspected. Of these, 26 faced show-cause notices, 11 stop-production orders, while two units are facing licence cancellation.
Flaws observed
- Non-functional air handling units
- Dysfunctional lab equipment
- Absence of proper maintenance of machinery
The phases of inspections were conducted from December to February and March to May. Two drug inspectors each from the state and the central authorities inspected units in various industrial clusters, including Baddi-Barotiwala-Nalagarh, Kala Amb, Paonta Sahib, etc.
“A pharmaceutical unit is jointly inspected by the state and central authorities at the time of granting a licence for manufacturing drugs. It is further inspected from time to time. Laxities are pointed out and got rectified, besides initiating various other steps,” said Navneet Marwaha, State Drugs Controller.
All units that were issued show-cause notices or ordered to suspend production would be inspected once again. Satisfactory compliance of norms by such units would lead to resumption of production, he added. It usually takes two-three months to rectify major laxities in a pharmaceutical unit.
The quality of drugs manufactured in the state has come under a cloud with at least four major cases of spurious drugs coming to the fore since September 2022. The death of 12 infants in the Udhampur area of Jammu and Kashmir in 2021 after consuming a cough syrup manufactured by Kala Amb-based firm Digital Vision had also besmirched the image of pharmaceutical industry in the state.
