Union government needs to issue a set of guidelines to assess the shelf life of Ayurveda, Siddha Unani (ASU) medicines as it has already decided to have expiry dates for ISM drugs. The guidelines would be appropriate to support the government’s recent notification calling the ASU sector to display the shelf life information on all its drugs, stated DBA Narayana, chairman, Herbal Products & Crude Drugs Committee, Indian Pharmacopoeia Commission.

The guidelines are critical for the ISM units if the government has to implement the decision successfully. The most important point is that guidelines will provide a concrete direction to the manufacturers to ensure that there is no confusion between the industry and the licensing authority, Dr Narayana told Pharmabiz.

To ascertain the durability of goods is a basic consumer right. Therefore it is only appropriate that ASU medicines also provide this information on the labels. It is a welcome step as it recognizes the herbal drugs as a modern pharmaceutical science by mandating shelf life for ASU medicines. However, it would have been appropriate that if along with this notification, the Government had also published a set of guidelines for assessing the shelf life of drugs. The notification also does not clearly state whether the periods prescribed are the maximum time from the date of manufacturing, said Dr Narayana.

In addition, the government has also not included a provision in the notification for approval of expiry periods more than that given in the announcement if the ASU firms provide data to support the same. In fact, this provision, which has been a demand from the industry, would have helped in meeting export consignment requirements, which take months to reach the destination countries. Adoption of proper packaging technology can provide longer life to the medicines, he added

According to JSD Pani, president, Karnataka Indian Medicine Manufacturers Association, the notification requiring to print expiry dates on labels was long overdue and this is the first move towards recognition of quality standards maintained during manufacture. Any product needs to have a shelf life. In fact this is most critical for plant and herb based drugs, he added.

The decision to carry the expiry date on the label is the best that could happen to the Ayush sector. With the government issuing the order through the State Directorate of Ayush, the entire sector including small-scale units are aware of it. For the small Ayush manufacturers, this move is a major step in the quality recognition, stated Dr Chitra Phadnis, CEO, Madhur Pharma & Research Laboratories Pvt Ltd.