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The Central Government has prepared to take a decisive attack on the increasing cases of misleading the general public through misleading advertisements of medicines, magical cures and health products across the country. The Union Ministry of Health and Family Welfare has issued a new draft gazette notification to amend the Drugs Rules 1945. Under this, strict legal restrictions will now be imposed on advertisements and aggressive promotion of prescription drugs by drug manufacturers, wholesalers, distributors and medical retailers. According to the proposed rules, it will be mandatory to obtain ‘Prior Central Government Approval’ from the Central Government for any kind of public or commercial promotion of drugs falling in Schedule H, Schedule H1 and Schedule Licenses of companies and drug sellers advertising on any digital platform, newspaper, TV, social media or medical brochure without approval will be cancelled, along with a case under criminal sections will be registered against them.
The main objective of this new rule, prepared after extensive discussions with the Drugs Technical Advisory Board (DTAB), is to curb the menace of ‘self-medication’ and acute antibiotic resistance (AMR) in the country. Currently, medicines for many serious diseases including painkillers, powerful antibiotics, depression and sleeping pills are being promoted by pharma companies and online e-pharmacy platforms through misleading claims, attractive offers and discounts. Common patients, influenced by advertisements, start taking overdose of these scheduled medicines without doctor’s advice, which is causing fatal problems like liver, kidney failure and ineffectiveness of the medicines. According to the new draft, now no licensed entity (shopkeeper or distributor) will be allowed to openly advertise the features, brand name or usefulness of such medicines, unless the scientific facts of that advertisement are thoroughly examined by an expert committee of the Health Ministry.
This strict action by the Central Government on medicines and medical promotion comes in continuation of the strict stance of the Supreme Court and the recent guidelines of the National Medical Commission (NMC). Recently, the Supreme Court had directed the Center to constitute a high-level committee on unethical drug promotion practices of pharmaceutical companies and the game of getting doctors to prescribe their medicines by giving expensive gifts and foreign trips. At the same time, NMC has also imposed a complete ban on the use of ‘number-1 specialist’, ‘100% successful treatment’, ‘miraculous results’ and sponsored reviews-testimonials of patients in the advertisements of doctors and private hospitals. Now the Health Ministry has drawn up a blueprint to completely eliminate the scope for misinformation in the entire healthcare ecosystem by cracking down on the other end of the supply chain i.e. drug manufacturers, distributors and chemists.
This step of the government is sure to have a deep impact on the pharmaceutical industry and the marketing model of the rapidly emerging e-pharmacy portals. Till now many companies used to resort to indirect ‘surrogate promotion’ through social media influencers, digital search ads and health blogs. After the new rules come into effect:
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Pre-screening of every promotional material: Drug companies will have to submit every script, creative and prescription of advertisements to the Central Drugs Standard Control Organization (CDSCO) for approval, making the approval process lengthy and complex.
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Ban on discount advertisements on online medicines: There will be a direct ban on promoting brands of scheduled medicines and advertising ‘flash sales’ or huge discounts on e-commerce platforms.
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Provision of penalty and jail: If there is a violation of the rules, under the Drugs and Cosmetics Act and Drugs and Magic Remedies (Objectionable Advertisements) Act, there will be a provision of heavy fine and jail sentence ranging from 6 months for the first offense to 1 year for the second offense.
As soon as this draft notification became public, there has been a stir among the wholesale and retail drug sellers in the country’s big wholesale drug markets – Delhi’s Bhagirath Palace, Uttar Pradesh’s capital Lucknow’s Aminabad drug market, Kanpur’s Nayaganj Market and Patna’s Govind Mitra Road. Representatives of All India Organization of Chemists and Druggists (AIOCD) say that the government should understand the difference between genuine pharmaceutical companies and small retailers. Many times shopkeepers put up posters related to diseases and vaccines in the interest of public interest and public awareness, on which new restrictions can create confusion. However, health workers, medical councils and senior doctors have strongly welcomed this move of the government. He believes that unless arbitrary advertisements of scheduled medicines are banned, it will not be possible to protect patients from medical plunder and life-threatening side-effects. The government has sought suggestions and objections from all stakeholders on this draft, after which it will be finally notified in the Official Gazette and implemented across the country.