Although there are provisions for labeling and packaging of drugs in the D&C Act, several manufacturers are not properly following them and often the regulatory officers have to take action against them for misbranded products.
This happens because the entrepreneurs are not very much concerned about the Rules specifying the labeling and packaging of drugs, commented Lalit Kumar Goel, deputy drugs controller, Haryana and resource person of the drug control officers association, DCO India.
He said all pharma entrepreneurs and industry captains should mandatorily follow the provisions of pharmaceutical labeling and pack size because they are meant to help the consumers to get the right information about the drugs they are taking.
Goel was presenting a power-point presentation on ‘Pharmaceutical Labelling and Pack Size’ in a seminar organized by the Haryana Drugs Manufacturers Association (HDMA) in Karnal recently.
According to him, the manufacturers should understand one fact that no drug can be sold without a proper label and if anybody violates the rule it becomes contravention of Rule 95 of the D&C Act. However, there are some exemptions for some provisions for export of drugs because of the requirements of the importing countries. But no alteration on the label of a drug can be done without the permission of the licensing authorities.
“Drug labels are essential to patient safety and effective medication management. The labeling of the outer and inner containers of the drug should be the same. But, there are lapses from many,” he said in his speech.
Later, while speaking to Pharmabiz, Goel said during inspections the regulators find many violations from the side of the manufacturers on labeling and packaging, ultimately the officers are forced to take action against them for misbranding. This happens because the manufacturers are not keen about the rules about the labeling and they give no priority to that area. For example, he said the generic name of a drug should be written larger than the brand name on the label, and brand name should be written below the generic name.
The seminar was organized by the Haryana Drug Manufacturers Association during its annual general body meeting. The program was presided over by RL Sharma, president of the HDMA
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