Issues of regulation of pharma industry

Source-This post on Issues of regulation of pharma industry has been created based on the article “Pharma regulation: A complex problem” published in “Business Standard” on 15 March 2024.

UPSC Syllabus-GS Paper-2– Issues Relating to Development and Management of Social Sector/Services relating to Health, Education, Human Resources.

Context– There were reports of a big fake drugs racket in Delhi recently. Further, the Government has notified the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024.

What is the existing system to ensure safety and quality of drugs in India?

1) Manufacturing facilities need to be licensed.

2) The details of inputs that go into manufacturing are inspected and recorded.

3) The qualifications of individuals in charge of manufacturing are prescribed.

4) Production facilities are continuously inspected by competent authorities.

Read more- National List of Essential Medicines (NLEM) and Drug Pricing in India

What are the issues in ensuring safety and quality of drugs in India?

1) Archaic legislation– The legislation is over 75 years old, with many patchwork amendments. Despite improvement in knowledge about effective regulation, most of this knowledge has not been incorporated into the regulation of drug quality.

2) Price control mechanism– The price control mechanism used in India interferes with the expenditure levels of manufacturers. This leads to compromise with quality of drug manufactured.

3)  Sale of fake medicine-The medicines could be fake or spurious and may have been substituted in place of the original medicines by unscrupulous middlemen.

4) Substituted medicine– This happens when the brand of medicine recommended by the doctor is not available. Thus, the dispensing person in the shop needs to be knowledgeable and give the patient exactly what is required.However,this does not happen because of unavailability of qualified persons.

5) Unauthorized pharmacies- There are many unauthorized pharmacies in operation. The regulatory responsibility is distributed across the Union and the state government which creates overlapping jurisdictions.

6) Presence of multiple regulator– There is a separate regulator to deal with the education, profession, and practice of pharmacists.

7) Lack of quality data-There is lack of robust data in the workings of drug industry and the prevalence of various kinds of failings.

What should be the way forward?

Drug traceability systems on public blockchains can potentially help improve the authenticity of medicines throughout the supply chain.
By associating each drug unit with a digital identity, stakeholders can easily track and verify its origin, authenticity, and movement across the supply chain.

Question for practice

What are the problems in ensuring safety and quality of drugs in India?