Union government has now restricted on advertisement of drugs coming under Schedule H, H1 and X drugs. In a notification issued vide GSR 289, April 2015, the government has amended the Rules 74, 74 A, 74 B, 78 and 78 A of the Drugs and Cosmetics Act 1940 after inviting objections and suggestions from all stakeholders as required under Section 12 read with Section 33 of Drugs and Cosmetics Act 1940 vide GSR No 176 (E) dated March 11, 2014.
The government in its recent gazette notification while amending the Rules has inserted in each of these Rules a statement which reads as ‘no advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with previous sanction of the Central government’.
“In view of the above, it is also likely that pharma companies would need to seek the permission of the Central government for drug launches coming under this category. This is a major development by the government as it indicates its concern about the health of the patients. With the growing number of brands, there is stiff competition which is leading to aggressive marketing. Stalling pharma companies from advertising about their brands is the best thing that could have happened,” said Dr BR Jagashetty, former national advisor (drugs control) to ministry of health & family welfare and former Karnataka drugs controller.
Going by the several adverse drug reactions, it is a good thing that the government has issued the amendment of Rules 74, 74 A, 74 B, 78 and 78 A of the Drugs and Cosmetics Act. In the wake of an educated patient population, advertisements can mislead the public, he added.
“However, in my view advertisement of any drug including over-the-counter (OTC) whether allopathic or Ayurveda need to be stopped or restricted. This is because advertisements are merely a platform which lead to fool the public,” Dr Jagashetty. pointed out.
Commonly consumed paracetamol which is used for control of fever and pain could harm the liver if it is excessively taken to control the symptoms. Even antibiotic abuse by patients is leading to kidney failures and skin reactions. The common man is totally unaware of such consequences which lead to unnecessary hospitalization and increase in medical expenses, he pointed out.
Despite the Drugs and Cosmetic Act, 1940 & Rules there-under mandate need for a prescription to purchase drugs from retailers and the presence of a registered pharmacist to advise the consumer on how to take the medicines, which are being violated. There are also number of instances of medicines being purchased based on advertisements. Considering the patient safety aspect which is of utmost importance, the government has taken right step to put a stop to advertisement thereby disallowing companies to advertise their new products. The advantage is that the registered medical practitioner who is the only appropriate and authenticated person will know about the new drug to be prescribed to the patient, stated Dr Jagashetty.