#IndianFDAVsUSFDA.
source:ChatGPT
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1. In 2005, there were 3 infants aged under 6 months in the US where cough & cold medications were determined by medical examiners or coroners to be the underlying cause of death.
2. More broadly, in that period (2004-2005), about 1,519 children under age 2 were treated in US emergency departments for adverse events including overdoses from cough and cold medications.
3. In the 1930s, there were more than 100 deaths (mostly children) in the US from #DiethyleneGlycol (DEG) poisoning, including from Elixir Sulfanilamide, which was given for coughs/sore throats. That tragedy helped lead to major drug safety laws.
4. There is no recent public record I found that gives a reliable count of how many deaths from FDA-approved or FDA-regulated cough syrups have occurred in, say, the last 10–20 years in the US specifically attributed to either contamination or misuse.
5. Many of the recent deaths globally from toxic cough syrups have been linked to products from outside the US.
6. The most noteworthy fact is that
the contaminated products which caused recent deaths abroad have not and cannot entere the US drug supply chain.
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Now the million dollar questions :
i. Are we deficient in technology?
ii. Are our Regulators deficient in
quality or in Character?
iii Are our FDA officers are as
accountable as their
counterparts in US - FDA
iv. Are our Drug Laws are so weak
to let loose all lapse?
v. Don't we have strong political
will to adopt Zero-Tolerance?
There are two institutions meant to safeguard the pharmacy profession and the integrity of medicines:
A. Department of Food and Drug Control
B. State Pharmacy Council
Both these institutions have their own inspectors.
Yet, despite that, medical shops continue to operate freely and openly even in the prolonged absence of pharmacists.
Due to the fear of pharmacy inspectors, the attendance of pharmacists in medical shops had slightly improved for some time.
However, after the government took over control of the State Pharmacy Council, inspectors have been left without an effective system to perform their duties, and once again, license conditions are being openly flouted, with unauthorized or fake persons running medical stores, posing a serious public health risk.
The Drugs Inspectors are unable to stop this menace.
It is also unfortunate that pharmacy-based NGOs in the state — such as the Indian Pharmaceutical Association and the Registered Pharmacists Association — have failed to rise issues affecting public health and patients safety..
POV: Bhagwan PS
The "Indian FDA" is not a single entity but refers to the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs, medical devices, and cosmetics in India. It serves a similar function to the U.S. FDA, ensuring the safety, efficacy, and quality of medical products. In addition, individual states, like Maharashtra, have their own state-level "FDA" to handle state-specific food, drug, and cosmetic regulations.
National regulatory authority Central Drugs Standard Control Organisation (CDSCO):
- The national regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices throughout India.
- Role:CDSCO regulates the quality of medical products through the implementation of the Drugs and Cosmetics Act, 1940.
- Headquarters:Located in New Delhi.
- Drug Controller General of India (DCGI):The executive head of the CDSCO, who is responsible for regulating pharmaceutical and medical devices. State-level authorities
- State FDA:Many states have their own Food and Drug Administration (FDA) to enforce regulations at the state level.
- Example:The Food and Drug Administration, Maharashtra is an example of a state-level body responsible for food and drug safety within Maharashtra. Other international relevance
- U.S. FDA India Office: The U.S. FDA also has an office in New Delhi to ensure that food and medical products exported from India to the U.S. meet U.S. safety standards.
