CDSCO uncovers data manipulation, SOP violations by public testing labs

NEW DELHI: In a startling revelation, India’s drug regulator has found large scale “data manipulation” and non-compliance with good laboratory practices (GLP) by public testing laboratories.

According to a government report, since July, 72 public testing labs have been audited. Of them, 39 were sent show-cause notices, nine were issued orders to stop testing, five were sent warning letters and six were issued suspension of testing orders, the report said.

The review of 22 such labs is in the process and yet to be concluded, the report further said.

These labs are required to comply with good laboratory practices.

However, a large scale of data manipulation has been revealed from these laboratories. The report did not mention the names of the laboratories which are not complying to the GLP.

“This is alarming,” said a person privy to the report. “The pharma companies send their samples for testing to these laboratories and a large-scale data manipulation has been seen with them. It has come as an eye opener,” added the person.The Central Drugs Standard Control Organisation (CDSCO), along with state drug inspectors, have been doing these inspections as part of a massive nationwide crackdown on spurious and substandard medicines.

At present Phase IV of risk based inspections (RBI) is ongoing.

India’s drug regulator had earlier pointed to an urgent need to review the current GMP and GLP regulations along with Quality Management Systems being followed by pharmaceutical companies during the RBI.

For the public laboratories, the inspections started in July. While only six laboratories were inspected in the month of July, the number has increased over the months from 29 laboratories in August to 72 till October.

Earlier in 2017, the Drug Controller General of India (DCGI) directed manufacturers to submit the self-assessment reports of their units along with self-certification, stating that they are complying with GLP requirements as per the Drugs and Cosmetic Rules and submit plans for remedying any violations.

A checklist was being put together by the Central Drugs Standards Control Organisation (CDSCO) to help manufacturers perform GMP-GLP evaluations.

The laboratory owners were supposed to self-assess their compliance with good manufacturing and laboratory practices (GMP/GLP), award themselves a quality rating and submit an audit report to the state drug regulator, a move aimed at improving manufacturing practices in India.

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