The State Drug Control Authority has clamped down on 11 pharmaceutical industries of Himachal, which compromise on quality in drug manufacturing, with immediate effect banning drug production.
Show cause notices have been issued to 18 pharmaceutical industries. The authority has taken this major action due to non-compliance of prescribed drug manufacturing rules and standards in the pharmaceutical industries.
The second phase of risk-based inspection of drug manufacturing units identified by the Central Drugs Standard Control Organization (CDSCO) and the State Drug Control Authority is being carried out.
In this series, so far 29 pharmaceutical manufacturing units have been inspected in Solan, Sirmaur and Kangra districts, out of which, after detecting flaws in 11 pharmaceutical industries, the State Drug Control Authority issued orders to stop production with immediate effect.
Five of these industries are from the BBN region, while three are from the Sirmaur district and three from the Kangra district.
There has been a stir in the pharma sector of Himachal since the strict action taken by the State Drug Control Authority against these pharmaceutical industries for flouting the standards in drug manufacturing.
It is worth mentioning here that under the instructions of the Union Ministry of Health, the Central Drugs Standard Control Organization and the State Drug Control Authority have started the second phase of joint investigation of the identified drug manufacturing units.
The joint investigation is being conducted in accordance with the laid down standard operating procedures. The main objective of this exercise is to ensure quality drug manufacturing.
In this series, risk-based inspection of 29 pharmaceutical units located in Himachal’s Baddi-Barotiwala-Nalagarh, Sirmaur, Una, and Kalaamb was done.
Prior to the initiation of inspections, drug manufacturing units were identified as at risk of manufacturing non-standard quality (NSQ)/adulterated/counterfeit drugs.
The State Drug Control Authority found lapses related to Schedule M of Good Manufacturing Practices (GMP) of the Drugs and Cosmetics Act, 1940 in 11 pharmaceutical industries located in Baddi-Barotiwala-Nalagarh, Sirmaur, and Kangra districts during the inspection, on which strict action is now being taken While doing this, drug production has been banned.
No compromise on quality will be tolerated
Confirming the action, State Drug Controller Navneet Marwah said that compromising on quality in drug manufacturing will not be tolerated under any circumstances. The authority is working on this issue under the policy of zero tolerance.