17 more pharma companies in HP told to stop manufacturing
Source: tribuneIndia.com
Seventeen more drug firms in various industrial clusters of Himachal Pradesh have been ordered to stop manufacturing for failing to adhere to the stipulated norms based on the third phase of joint inspections conducted by the state and central drug regulatory authorities since August. Similarly, seven drug-testing labs have been ordered to stop operations.
The drug firms are supposed to adhere to Schedule M of the good manufacturing practices (GMP) under the Drugs and Cosmetics Act, 1940, while the labs are supposed to comply with the good laboratory practices to ensure quality.
As many as 74 drug firms have been inspected in the three phases of risk-based inspections being conducted since December 2022. While a total of 39 firms were issued stop manufacturing orders in the three phases, merely 10 firms have rectified the deficiencies.
As many as 29 firms, however, are yet to address their shortcomings since May and continue to remain closed, reflecting the seriousness of the shortcomings. “Usually, three-four months are required to rectify the shortcomings pointed out in the joint inspections. A unit is re-inspected jointly after it claims to have rectified the defects,” said Navneet Marwaha, State Drugs Controller, Baddi. Issues like inappropriate documentation which included lack of proper record of testing of drug batches, apt maintenance of the machinery including its timely validation and calibration, non-functional air handling units and dysfunctional lab equipment in micro-labs have come to the fore in the inspected firms.
“A key laxity in regular maintenance of heating ventilation and air conditioning (HVA) units has also come to the fore,” he said. Pharmaceutical units whose drug samples are repeatedly declared “not of standard quality” are being inspected in the industrial clusters of Baddi-Barotiwala-Nalagarh, Mehatpur, Sansarpur Terrace, Kala Amb and Paonta Sahib.
The drug regulators have, for the first time, inspected the 12 drug testing labs in the state. “Seven of them have been slapped with stop testing orders for failing to meet stipulated norms. These labs play a key role in testing drug batches before they are released into the market,” said Marwaha.
Alarming situation
- Drug samples manufactured in the state regularly figure in the monthly alerts of drugs declared “not of standard quality” (NSQ) by the national drugs regulator
- As many as 12 of the 48 drugs declared NSQ in September pertained to Himachal
