Contributing

What is the FDA equivalent in India?

What is the FDA equivalent in India?

India Central Drugs Standard Control Organization
CDSCO Overview – India Central Drugs Standard Control Organization. The Central Drugs Standard Control Organization is the Indian regulatory body for pharmaceuticals and medical devices, being the equivalent of the FDA in the US.

Who is the drug inspector of Mumbai?

Sachin Kamble – DRUG INSPECTOR – FDA-Maharashtra, INDIA | LinkedIn.

Is there FDA in India?

FDA opened the India Office in New Delhi in 2008, to ensure that food and medical products exported from India to the U.S. are safe, are of good quality, and are effective. FDA activities in India include: Conducting inspections of medical products and foods facilities that export to the U.S.

Who controls drugs India?

The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.

What is Drug inspector salary?

According to the Pay Matrix Level – 7 a drug inspector earns somewhere between INR 44,900 per month to INR 1,42,400 per month.

What is qualification for drug inspector?

To be eligible to become a drug inspector, a candidate must have completed his graduation in pharmacy or pharmaceutical science or clinical pharmacology or microbiology or medicine or any other equivalent qualification from a recognized institution.

Are generic drugs safe in India?

In the post-expiry phase, other drug-makers may manufacture the same drug and sell it under an international nonproprietary name – typically at a lower cost. Because generics break this affordability barrier, Indian law allows doctors to prescribe generic drugs to patients and for pharmacies to sell them.

Is it legal to get drugs from India?

Legal Background Under the NDPS Act, it is illegal for a person to produce/manufacture/cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance. Under one of the provisions of the act, the Narcotics Control Bureau was set up with effect from March 1986.

How do I get FDA certificate?

What is the Procedure for Obtaining FDA Certification?

  1. FDA officials visit the food and drug plants in foreign countries.
  2. The official of FDA then issues the Form 483 to the manufactures after the completion of the inspection.
  3. The FDA also issues an EIR (Establishment Inspection Report).

When did the FDA open an office in India?

Established in 2008, the India Office serves as the lead for the U.S. Food and Drug Administration’s (FDA) on-site presence in India. The India Office addresses operational and policy matters concerning FDA-regulated products in collaboration with Government of India counterparts.

What are the activities of the FDA in India?

FDA activities in India include: Conducting inspections of medical products and foods facilities that export to the U.S. Engaging with Indian regulatory authorities to build confidence in each other and develop quality standards Partnering with Indian counterpart agencies on bilateral initiatives

Is there a Food and Drug Administration Office in India?

Food and Drug Administration India Office. FDA opened the India Office in New Delhi in 2008, to ensure that food and medical products exported from India to the U.S. are safe, are of good quality, and are effective.

Why is FDA conducting commodity specific inspections in India?

Conducting commodity-specific inspections to meet the requirements of FDA-specific legislative mandates;