C.H. Unnikrishnan
The ministry of health and family welfare, in a notification issued in the last week of October, said it has amended the Drugs and Cosmetics Act to include a rule that mandates Ayurveda, Siddha and Unani drug makers to display a date of expiry on the label of the container or package. The new law will be effective from April.
So far, alternative healthcare systems did not need to fix a shelf life for their medicines as is done for allopathic or modern drugs. These traditional medicines have been consumed irrespective of the date of manufacture and their potency to remain efficacious beyond a period.
The new rule allows a maximum life period of between one and five years for different Ayurveda, Siddha and Unani medicines.
The amendment also standardizes manufacturing, packaging and storage practices for the traditional drug industry, which caters to a market worth around Rs8,000 crore.
Its implementation will also force old inventory out the market in the next few months as part of a voluntary filtration the industry will initiate to recall outdated products.
“With no scientific validation of product stability and quality standardization ever insisted upon for traditional medicines earlier, there was misconception in the market that these drugs need not to be evaluated for shelf life,” said D.B. Ananthanarayana, an Ayurveda scientist and chairman of herbal products and crude drugs at the Indian Pharmacopoeia Commission.
“But the new move is surely in the interest of the industry as well as consumer, though a guideline of how shelf life study of these medicines (is) to be performed while implementing the rules would have been very useful,” he added.
The ministry in the notification has specified the maximum shelf life on the basis of the formulation process, stability of active ingredients and the life period of the material that goes into formulations such as tablets, liquids, capsules and creams.
The expiry specifications are formulated on the basis of research and manufacturing process data submitted by the industry, as well as scientific validation of drugs by the Central Council for Research in Ayurveda and Siddha, a Union government body that publishes the pharmacopoeia for Ayurvedic and herbal medicines.
Ranjit Puranik, secretary general of the Ayurvedic Drug Manufacturers Association, or Adma, and chief executive of Mumbai-based Ayurveda firm Shree Dootapapeshwar Ltd, said the new rule is an effort towards modernization that would help the industry.
But, he added, some suggestions by Adma such as a longer shelf life for products based on the individual data furnished by manufacturers were not considered by the government.
“This suggestion, which will permit higher expiry date approval for export and domestic purposes on the satisfactory evidence provided by the manufacturer, was actually on the lines of the extended expiry for allopathic drugs and other types of products,” he said.
“It’s a very progressive and positive step and is aimed at empowering the consumer,” said a spokesperson for Dabur India Ltd, which sells the Ayurvedic nutritional supplement DaburChyawanprash.
Not everyone agrees.
“Some units will be producing more than 500 products in different categories. But out of this, only 15% are income-generating products, whereas the rest 85% is prescription medicines or slow-moving products,” said D. Ramanathan, CEO of Kerala-based Sitaram Ayurveda Pharmacy and Hospital Ltd, and general secretary of the Ayurveda Medicine Manufacturers of India. “If these regulations are implemented, the slow-moving items will be hit hard, and slowly...will have to be withdrawn or stopped altogether.”
Source: liveMint
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