[Answered] The pharmaceutical industry’s self-regulation is a deceptive blocking strategy rather than a means for the industry to police itself. Comment

Introduction: Contextual introduction.

Body: Explain how the pharmaceutical industry’s self-regulation is a deceptive blocking strategy. Also, write some solutions.

Conclusion: Write a way forward.

Pharmaceutical regulations across the world play an important role in ensuring the safety and efficacy of approved drugs. They not only regulate the pricing of drugs, but the quality as well. Self-regulation includes arrangements for enforcement, including publication of cases, and demonstrates the industry’s commitment to high standards, increasing public trust, and combating negative public perceptions.

A deceptive blocking strategy:

  • Several complaints regarding “unethicalpractices by pharmaceutical companies.
  • It can push doctors to over-medicate self regulation patients or make them buy pricier alternatives, which violates the fundamental maxim of healthcare: do no harm.
  • It alleged that doctors were bribed with “travel expenses, perquisites, and gifts”.
  • It is treated as a basis to dodge regulations, and then its failure invites regulatory scrutiny and eventually regulations.
  • The basic business principle of profit maximization poses a big obstacle to self-regulation.
  • Allegedly bribing the Central Drugs Standard Control Organisation (CDSCO) officials.
  • In a country where law enforcement is weak and legal redressal can take ages, a voluntary code of conduct hardly acts as a deterrent.

Solutions:

  • Implementing the recommendation of Malshekar committee on drug regulation: a new structure for the Drug Regulatory System in the country including the setting up of a National Drug Authority and recommended that the State Drug Control Organisations should be urgently strengthened.
  • Revise the ethical code for Pharma companies to discontinue freebies and gifts.
  • Government need to upgrade the quality standards and qualitiesof Medical representatives and drug sellers.
  • The issue of non-uniformity of enforcement at the state level is serious and needs to be addressed immediately.

Though the pharmaceutical sector is highly capital-intensive, it has developed into a global leader in pharma products. Now it is time to implement better policies in regulations.

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