Drugs panel against green dots on veg capsules

A fresh proposal to put “green dots” on drug capsules of vegetarian origin has been rejected by a Health Ministry’s  technical panel.

After the NDA government came to power, the health ministry received representations on labelling the capsules made of cellulose with green dots to distinguish them those made from gelatin, which are of animal origin.

“Unlike food, drugs are not taken by choice, but are prescribed by the doctors to save lives. Marking them vegetarian or non-vegetarian origin is not desirable,” the Drug Technical Advisory Board (DTAB) ruled in its meeting two weeks ago.

The proposal was to mark the cellulose-based capsules with green dots, while the gelatine-based ones are to be sold as it is. While gelatin is more common, a monograph on the cellulose-based capsules is under the consideration of Indian Pharmacopoeia Commission, sources told DH.

The new effort to differentiate between capsules of vegetarian and non-vegetarian origin comes more than a decade after the first attempt – initiated during the Atal Bihari Vajpayee regime – was rejected by the Supreme Court in 2013.

On a PIL, the Delhi High Court ruled in 2002 that drugs and cosmetics would have to carry red and green dots, depending on their origin. The ruling was overturned by the Supreme Court in 2013.

The DTAB, in its last meeting on May 13, also recommended not to use plastic bottles to store oral formulations for paediatric and geriatric use as well as medicines for pregnant women and women in reproductive age.

The panel relied on a fresh set of test data that suggests leaching of heavy metals from plastic bottles into the medicine even at room temperature.

DTAB stood by its earlier recommendations on the basis of which the health ministry issued a draft notification in 2014 prohibiting use of plastic bottles for storing liquid medicines meant for children, the elderly and women. The notification was challenged by the industry.

Tests conducted by the All India Institute of Hygiene and Public Health, Kolkata, and National Test House showed leaching of antimony, chromium, lead and other toxic chemicals even at room temperature.

Besides room temperature, the samples were also tested at 40 degrees Celsius and 60 degrees Celsius. Leaching was found every time.

The technical panel rejected a report by another expert panel, headed by former department of biotechnology secretary M K Bhan, which found “no conclusive and reproducible evidence” to suggest these bottles leach out any harmful chemical in the drugs that they contain.