The Bangalore Mahanagara Palike (Bangalore City Corporation) is all set to clamp down on chemists and druggists who fail to declare on the label of each package of food article/nutraceuticals, the nature of the product - non vegetarian or vegetarian.
The rule stipulates that the product label must indicate its content by displaying a prominent symbol in the form of a brown dot for animal origin and green dot for vegetarian origin. Non-displaying of these dots is a violation of Rule 32 and Rule 34 of the Prevention of Food Adulteration Act (PFA). The BMP's PFA section will make surprise inspections at all outlets in the State beginning with Bangalore jointly with the Karnataka State Drugs Control Department and BMP PFA inspectors beginning next week.
The union ministry of health and family welfare has issued an amendment of the Prevention of Food Adulteration Rules 1955 with effect from October 4, 2001 making it mandatory for companies to declare the origin of the contents on the label.
Rule 32 states that product containing any non-vegetarian ingredient should mention a symbol and colour code as stipulated which is brown filled circle inside a square with a brown outline having sides double the diameter of a circle. It further states that whenever gelatine is used as an ingredient in the manufacture of a product, a declaration to that effect shall be made on the label by inserting 'Gelatine- Animal origin' either in English or Hindi. Rule 34 states that a box shall surround the declaration.
Dr. R K Kumaraswamy, chief health officer, BMP told Pharmabiz.com that if companies are found to be violating the rule, the product will be treated as misbranded one after which they will be prosecuted.
He said that his section would be empowered to conduct checks at the druggists and chemists outlets with the cooperation of drug inspectors from the Karnataka Drugs Control department whose inspectors can accompany the food inspectors. ``All that we need is a letter from the Drugs Controller to curtail the activities. There will be no warning as the aim of law is to prevent violation of the rules.'' Asked why action had not been taken previously, he said, ``there was a transitional phase for the law to take effect and hence no action could be taken during this period.''
According to R Anand Rajashekar, drugs controller, government of Karnataka, the PFA does not come under the purview of the Drugs department. No drug inspectors will check for violations of the PFA act as it comes under the control of food inspectors. But the irony is that no food inspector can visit the chemists and druggists outlets, as they do not hold a drug licence to check for violation of the Rules 32 and 34. Now with the BMP's PFA section planning the inspection drive, the drugs department officials will accompany them for the checks.
The observation is that nutraceuticals companies are not abiding by these rules despite orders to stop advertising products, which claim to be pure vegetarian though gelatine capsules shells, are used. The Kerala High Court early this year had made it mandatory for all nutraceuticals to abide by the law after Parrys Nutraceuticals violated the rule.
The Delhi High Court recently ordered naming of animal extracts on the packs after complaints from customers.
The government has already made it mandatory for manufacturers to indicate on every packed food item the presence of animal extracts. The same principle will also apply to non-life saving drugs like nutraceuticals. Life saving drugs however is out of the purview of the order considering the fact that a more important question of saving the life of the person was involved.
The pharmaceutical companies engaged in the production of nutraceuticals from Karnataka are Micro Labs (Biovital), Strides Arcolabs, Zydus-Recon (Recolina), Anglo French, AstraZeneca Pharma India, Banner Pharmacaps (Insumin and Madonia), apart from Universal Medicare and Emcure Pharmaceuticals. It has been found that companies are contradicting the message on the labels and claim that the capsules are 100 per cent vegetarian. At the same time, the label also mentions that the capsule shells are made of gelatine. The packaging proves that there is no compliance to PFA's Rule 32 and 34.
Pharmabiz.com has received a list of products and the companies violating PFA Rule 32 and 34. Some of the products include Mega-3 manufactured by Sai Mirra Pharmaceuticals Pvt. Ltd, Ub-Q (Fourrts (India) Laboratories Pvt. Ltd., Manovit (Atoz Pharmaceuticals Pvt. Ltd.), I-Vit Plus (Semit Pharmaceuticals & Chemicals Pvt. Ltd.), Pantoplex (Colinz Laboratories), GLA-120 (Dr. Reddys Laboratory Limited) Ega (Atoz Pharmaceuticals Pvt. Ltd.), Native-200 (Softesule Pvt. Ltd.), Eldervite-ZC (Elder Pharmaceuticals Ltd.), Slim-U Plus (Vibes India), Recolina Zydus-Recon, Imax-60 (Madras Pharmaceuticals), Cartilamine and Cartilamine SR (Triokaa Pharmaceuticals) and OG-3 Veg (Banner Pharmacaps).