DRUGS AND MAGIC REMEDIES OBJECTIONABLE ADVERTISEMENT ACT, 1954

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Context

• Advertisements promising miraculous cures often mislead the public and prompt legislative measures like the Drugs and Magic Remedies (Objectionable Advertisements) Act to curb these claims.
• Last week, the Central Drugs Standard Control Organisation (CDSCO) suspended a pharmaceutical company’s permission to manufacture and market eye drops for presbyopia.

What was the issue?

• The company, ENTOD Pharmaceuticals, claimed that its eye drops could eliminate the need for reading glasses in patients with presbyopia, a claim not authorised by CDSCO.
• CDSCO intervened to prevent the public from being misled, citing concerns of public interest.
• The key component, pilocarpine, constricts the pupils, creating a pinhole effect to improve vision for presbyopia patients.
• Pilocarpine is not a new drug. It has been used in ophthalmology to treat glaucoma but fell out of favor due to side effects, replaced by better alternatives.
• The CDSCO’s decision reinforces the Drugs and Magic Remedies Act, ensuring that pharmaceutical companies do not make unsubstantiated claims.

Read about the issue: https://www.iasgyan.in/daily-current-affairs/presbyopia

About CDSCO

Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

• It was enacted by the Parliament to control the advertising of drugs and remedies, particularly those claiming to have magical properties.
• Advertising such remedies is a cognizable offence under this law.
• "Magic Remedy" includes any talisman, mantra, amulet, or object claimed to have miraculous powers to cure, prevent, or diagnose diseases.
• This also extends to devices said to influence the structure or function of human or animal organs.
• Drugs and Magic Remedies Objectionable Advertisement Rules,1955 were enacted to ensure effective implementation of the act.

Prohibited Advertisements

The Act bans the advertisement of drugs or remedies that claim to:

• Induce miscarriage or prevent conception in women.
• Improve or maintain the capacity for sexual pleasure.
• Correct menstrual disorders.
• Cure, diagnose, or prevent any disease or condition listed in the schedule attached to the Act.

List of Diseases and Conditions in the Original Schedule

• The original schedule included 54 diseases and conditions for which advertisements are prohibited.
• Diseases: Appendicitis, Cancer, Diabetes, Heart diseases, Tuberculosis, and Venereal diseases.
• Disorders: Menstrual flow disorders, Nervous system disorders, Prostatic gland disorders.
• Conditions: Sexual impotence, Paralysis, Obesity, Insanity, Leprosy.

Amendments to the Schedule

• The Act allows for changes to the schedule through consultation with the Drugs Technical Advisory Board, and if necessary, with Ayurveda and Unani practitioners.
• These changes are required for diseases where no accepted remedies exist or where timely consultation with a registered medical practitioner is essential.

Penalties

• First Conviction: Maximum imprisonment of 6 months, with or without a fine.
• Subsequent Convictions: Up to 1 year imprisonment.
• If a company is involved, all members of the company are deemed guilty.

Criticism

• Lack of Enforcement: The Act is rarely enforced, allowing several such products to be freely advertised to the public.
• Outdated List: Fourteen of the diseases listed are now curable, and newer diseases like AIDS are not included.
• Cable Television Advertisements: Ads for prohibited categories still appear on TV without significant consequences.
• Traditional Medicine Systems: Proposed amendments have raised questions about the relationship between modern medicine and traditional systems like Ayurveda and Yoga.

Drugs and Cosmetics Act, 1940

• It regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India.
• The primary goal of the Act is to ensure that drugs and cosmetics sold in the country are safe, effective, and conform to quality standards.
• The Drugs and Cosmetics Rules, 1945 complement the Act by classifying drugs into schedules and providing guidelines for their storage, sale, and prescription.

Key Definitions

• Drug: Includes substances, diagnostic tools, and medical devices.
• Cosmetic: Refers to any product applied to the human body for beautification or cleansing, excluding soaps.

Important Sections

• Section 16: Defines the quality standards for drugs.
• Section 17: Defines "misbranding" of drugs, where a drug is considered misbranded if it claims more therapeutic value than it possesses.
• Section 18: Allows the government to suspend the manufacture of misbranded drugs.
• Section 22: Defines the powers of drug inspectors.
• Section 23: Specifies the procedures to be followed by drug inspectors during inspections or raids.
• Section 27: Addresses fake and adulterated drugs, requiring accurate labeling of ingredients.

Controversy

The Act has been criticized for its lack of specific penalties related to clinical trials.

Sources:

Hindu