Government weighs stricter norms, heavy fines in draft Drugs and Cosmetics Act

New Delhi,  October 2016:

The government is considering measures, including imposing heavy fines and imprisonment, in the draft Drugs and Cosmetics Act to prevent pharmaceutical companies from violating manufacturing norms, according to two health ministry officials.

Consistent violations of the Good Manufacturing Practices (GMP) may invite not just suspension of drug licenses, as is the case now, but also stiff fines and even imprisonment of executives.

Recalling batches of drugs that fail to conform to standards of strength, quality or purity is likely to be made mandatory after being notified by the drug regulator. Recalls are now made voluntarily or upon a directive being issued by the licensing or controlling authority.

The government also plans to expand the definition of spurious drugs by tying it to a product's active pharmaceutical ingredient-which could be substandard or inefficacious. A product's active pharmaceutical ingredient is the central ingredient that is chemically active and produces the desired effect upon ingestion.

"The changes are sort of an extension of the government's focus on ensuring GMP guidelines are followed. The punitive measures will also be commensurate with the severity of the offences committed," said a senior health ministry official, one of the two cited earlier. Both officials spoke on condition of anonymity.

The Central Drug Standard Control Organization (CDSCO) had earlier this year evolved risk-based criteria for inspecting the drug manufacturing sites in the country. The overall scheme, with around 150 metrics, gives different factors varying weights to gauge compliance.

"The CDSCO has with this in view evolved a draft checklist and an evaluation tool for undertaking inspection of such sites and reporting findings of such inspections to the CDSCO and the state drug regulators concerned," the CDSCO notification stated.

The steps to harmonize the rules with global standards are long overdue, say industry analysts.

"This should have been done much earlier. If you look at the United States Food and Drug Administration, the focus on following due process is quite clear, as should be the case," said Muralidharan Nair, partner, life sciences, at consulting firm EY.

Earlier this year, the government scrapped a plan to amend parts of the Drugs and Cosmetics Act of 1940 in favor of a new law. The bill to amend the law had been pending following its introduction in Parliament for some time, and in various committees for years prior, before it was withdrawn.

"The cabinet has, keeping in view the role of the sector in managing public health, decided that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial/investigation, etc., cannot be effectively regulated under the existing law," the government had said while withdrawing the bill.

The government had also decided to formulate a separate law for medical devices, the draft rules for which have been recently shared in the public domain.

"The new Drugs and Cosmetics Act would be much more comprehensive in all aspects-from the focus on compliance to regulatory issues to improving clinical trial standards in the country," said the second of the two health ministry officials cited earlier. Liv Mint