With the rapid increase in interest from international markets for the drug and medical device industries in the Indian market, the various bodies governing healthcare are aiming to tighten regulations with an interest on patient safety. Pertaining on the issue of storage temperature on medicine labels, the Indian Pharmaceuticals Association (IPA) wants the Drug Controller General of India (DCGI) to formalize some guidelines. During a cross country study, the IPA found that most of the products do not have proper labeling and some surprisingly don’t even have the label for storage instructions. To solve this non-uniformity with the labels, the IPA has strictly said it should be made mandatory to have labels of minimum storage temperature and medical products without such labels must be terminated from the Indian market.

The DCGI is controlled by the Drugs and Cosmetics Act of 1945. Medical devices were largely unregulated since its inception. Since 2009, medical device regulations have been separated from pharmaceutical regulations. Clearly defined labeling requirements for medical devices were formulated in 2014 and constant updates based on panels such as IPA, medical device advisory boards are being made.

The IPA also insists a clear-cut temperature specification as current labeling doesn’t specify proper temperature as it reads ‘room temperature’, ‘store in cool place’ which is very confusing and ineffective as different parts of the country will have different climates. The general secretary of the IPA, Kaushik Desai said: “There is should be clear mention to room temperature which should include range of both upper and lower temperature to avoid all the non-needed statements in the label which confuses the people.

He added “The guidelines for the storage temperature labels should be structured on a priority considering the risks involved. The steps for implementing the proposed GDP by DTAB should also be taken by the CDSCO immediately.”



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