In a move to promote sales of generic, and therefore affordable, drugs, the Government of India (GoI) has for the first time specified that the generic name of medicines printed on the packages should be larger by two font sizes than the brand name.
The rule will be enforced from September 13 this year. Previous rules specified that the generic name should be printed prominently, but did nit have specific instructions.
Drug manufacturers have welcomed the move but said uniformity needs to be brought in efficacy of generics drugs. Medical store operators said that apart from a handful of generic drug manufacturers, other manufacturers have acceptable norms of quality of medicines.
“This is another step in promotion of generic drugs. The move will create awareness about generic drugs among the users,” said Viranchi Shah, chairman of Indian Drug Manufacturers Association (IDMA) – Gujarat chapter.
He, however, cautioned that there are no standards in the country to ensure that the effect of generic drugs on the patients is uniform and that manufacturers that spend money on the impact of drugs on patients will be at a loss.
“The price of branded drugs is higher because leading brands spend money to maintain the quality of the drug. This could be a differentiater if the patient is suffering from cardio-vascular diseases, cancer, diabetes or other ailments,” said Shah.
Players also said that they will have to redesign entire packaging and in spite of promotion of generic medicines, people may not switch to cheaper drugs as they are not ready to compromise on the treatment of their loved ones.
While the concept of generic drugs has gained ground in the countries of Europe, it is because they have a mechanism to ensure that the quality of generic drugs is uniform, independent of the manufacturer, which is not the case in India.
Ketan Patel, CMD of Troikaa Pharmaceuticals Ltd, suggested that instead of rolling out regulations in bits and pieces, the government should issue all directions at one go so that manufacturers have a clear road map for compliance and keep costs under control.
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