What is the name of drug controller in India?
Dr. V. G. Somani
The present Drug Controller General of India is Dr. V. G. Somani. He was appointed on August 14, 2019.
How many zonal offices are there under Cdsco?
six zonal offices
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
Where is Cdsco located in India?
Government of India
Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the country.
Who is highest authority in Cdsco?
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
What is the work of drug controller?
Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
Who is responsible for approval of drugs?
The FDA
The FDA must regulate and approve new prescription drugs before they can be sold to the public.
Who is the head of Drug Controller General of India?
Dr. Venugopal G Somani is the Drugs Controller General of India (DCGI) since July 2019. Dr.
What is the difference between Dcgi and CDSCO?
The Central Drug Standards Control Organisation (CDSCO) is India’s main regulatory body for medical devices. The Drug Controller General of India is an important office within the CDSCO. DCGI is responsible for authorising the production of medical equipment.
What is the difference between CDSCO and Dcgi?
Is drug inspector a good job?
Drug Inspectors are appointed by various central and state government departments like Health and Family Welfare. A career as a drug inspector is indeed one of the most promising and well-rewarded careers for those fulfilling the eligibility.
How long does it take for a drug to be approved?
There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage. But this time span varies a lot. There are many factors that affect how long it takes for a drug to be licensed.
Which agency approves new drugs?
The FDA must regulate and approve new prescription drugs before they can be sold to the public.
What is FDA called in India?
Established in November 2008, the Office of Global Policy and Strategy’s (OGPS) India Office (INO) serves as the lead FDA on-site presence in New Delhi, India. The India Office addresses operational and policy matters concerning FDA-regulated products in collaboration with the Government of India counterparts.
What is qualification of drug?
Essential Qualification:
Must be holder of B. Pharma degree in Pharmacy. Must have put in a service of not less than eighteen months of experience in the manufacturing and or testing of schedule C and / or C1 drugs included in the Drugs and Cosmetics Rules, 1945.
Is drug inspector exam difficult?
The Exam to become drug inspector is not that easy, there is huge competition in this field as well. One will have to prepare very well for the examination. The paper is not that tough but the competition is too much in this field.
How much does it cost to get a drug approved?
In an analysis of the drug development costs for 98 companies over a decade, the average cost per drug developed and approved by a single-drug company was $350 million.
Why do drug trials take so long?
Establishing a safety profile of a drug is a key reason why the process of drug development takes time. There are numerous studies that regulators require in determining if a drug is safe enough to be dosed in humans—and these safety studies continue throughout clinical trials and the drug’s lifecycle.
What are the 4 stages of drug development?
Information For
- Step 1: Discovery and Development.
- Step 2: Preclinical Research.
- Step 3: Clinical Research.
- Step 4: FDA Drug Review.
- Step 5: FDA Post-Market Drug Safety Monitoring.
How long do drug trials take?
Clinical trials alone take six to seven years on average to complete. Before the potential therapy enters the clinical trial stage, researchers begin by investigating ideas in the discovery phase, which typically takes three to six years.
Where is FDA located in India?
Established in November 2008, the Office of Global Policy and Strategy’s (OGPS) India Office (INO) serves as the lead FDA on-site presence in New Delhi, India.
How many drugs are in India?
A total of 348 medicines (excluding repetitions) are present in NLEM 2011. In the NLEM 2011, 181 medicines fall under the category of P, S and T, 106 medicines fall under the category of S, T while 61 medicines are categorized as T only.
Can MBBS become drug inspector?
A candidate who completes his graduation in pharmacy or pharmaceutical science or medicine with specialization in clinical pharmacology or microbiology are eligible to apply for the drug inspector post.
Which degree is best for drug inspector?
Bachelor’s degree in Pharmacy
Drug Inspector Eligibility 2022: Educational Qualification
The candidate should have a B. Pharma or Bachelor’s degree in Pharmacy. For B Pharma, the candidate must have passed 12th with Physics, Chemistry and Biology / Maths subjects. Its duration is four years.
What is the power of drug inspector?
The recent judgement of the Supreme Court concluded that for offences committed under Chapter IV of the Drugs and Cosmetics Act 1940, only the ‘Drug Inspector’ has the powers to investigate any complaint, institute prosecution and even arrest the offenders.
How many new drugs fail?
Drug discovery and development is a long, costly, and high-risk process that takes over 10–15 years with an average cost of over $1–2 billion for each new drug to be approved for clinical use1.