Punjab FDA restricts sale of bulk packs of products with high alcohol content

The Punjab Food and Drugs Administration (FDA) has restricted the sale of bulk pack sizes of alcohol-containing products such as hand sanitisers, disinfectants and hand rubs in the open market but has permitted the sale of packs up to one litre.

However, the State FDA has allowed the sale and distribution of bulk packs above one litre for supplies made to government institutions/government-supported institutions, boards, councils and corporate sectors for export purposes.

In the State, the above-mentioned products are available in the market in bulk packs, namely; five-litre to 50-litre packs in plastic cans. Reportedly, besides authorised chemist shops, these products are also available at hardware shops, grocery stores, stationery shops etc.

The Punjab FDA has made a provision that valid NOC holders from the fire department and the Punjab Pollution Control Board need to submit a self-attested copy to State FDA for manufacturing and storage of bulk packs in their premises.

The FDA has also announced that any person, manufacturer or seller of bulk packs found without valid permission will be liable for action in accordance with the law.

Commenting on the need for this move, Pradeep Mattu, Joint Commissioner, Food and Drugs Administration, Punjab informed, “Hand sanitiser preparations contain 65 to 75 per cent of alcohol yet it was observed that bulk packs of these products are not stored properly and can cause leakage. Since alcohol is volatile in nature and inflammable, this can cause fires and create risks for human life.”

He cited the example of homoeopathic medicines to justify the step taken by Punjab FDA.  He pointed out that as per provisions under Section 106 B of The Drugs and Cosmetics Rules, 1945, which deals with the prohibition of quantity and percentage of alcohol-containing preparations, homoeopathic medicines containing ethyl alcohol shall be packed and sold in packing or bottle of not more than 3O ml. It may be sold to hospitals/clinics in not more than 100 ml packs. Though this rule is not relevant to drugs under allopathic/cosmetics licences it is indicated that the storage of preparations with high alcoholic content is risk-generating if stored in hefty quantities.

He explained, “Besides casualty concerns, it also creates trouble for us in collecting samples of bulk packs from the market during the process of verifying product quality.”

Commenting on the availability of hand sanitisers in stores other than chemist shops, Mattu said, “Understanding the pandemic situation in the country, availability should be considered a priority along with safety methods and quality parameters. Therefore, in Punjab, we have allowed the sale of qualified hand sanitisers sale in all types of stores which includes grocery stores as well.”

[email protected]
[email protected]