Source: IPLEADERS

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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

 

PRACTICE QUESTION Q:Consider the following: It regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Drugs and Cosmetics Rules, 1945 were enacted to ensure effective implementation of the act. Medical devices are not covered under the act. Which of the above statements is/are not correct in reference to Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954? a) 1 and 2 only b) 2 and 3 only c) 1 and 3 only d) 1, 2 and 3 Answer: d Explanation: ●Statement 1 is incorrect: It was enacted by the Parliament to control the advertising of drugs and remedies, particularly those claiming to have magical properties. ●Statement 2 is incorrect: Drugs and Magic Remedies Objectionable Advertisement Rules,1955 were enacted to ensure effective implementation of the act. ●Statement 3 is incorrect: The act also extends to medical devices said to influence the structure or function of human or animal organs.