(a) Discuss the evolution of Indian 5x2 Pharmaceutical Industry. (b) Highlight the Global and Indian scenario in Pharmaceutical sector. (a) What are the functions of the National Pharmaceutical pricing authority ?
5x2
(b) Briefly explain the regulatory authority in India. (a) Briefly discuss the phase I clinical trial. (b) Define the importance and significance of phase IV clinical trial.
5x2
(a) Discuss the procedure of filing the New Drug Application (NDA).
6
(b) What are the different types of Investigational new drugs ?
4
MVE-004
1
P.T.O.
5.
(a) Explain the approval process for vaccine. Give the full form (of any three) of the following bodies : (i) RCGM (ii) GEAC (iii) IBSC (iv) DBT (v) ICMR What is the composition of GEAC ?
6.
(a) Write short notes on any two : Poison Act MRT Act
4 3
3 6
Pharmacy Council of India NDPS Act (b) What is Drugs and Magic Remedies (Objectionable Advertisement) Act ? 7.
(a) Describe the adulterated drug. (b) What do you understand by misbranded drugs ?
8.
Write short notes on any , two : Drug Price Control Order (DPCO) Drug Technical Advisory Board (DTAB) (c) Labelling requirement on Pharmaceuticals -o0o-
Pharmaceutical Industry. ... MRT Act. Pharmacy Council of India. NDPS Act. (b) What is Drugs and Magic Remedies 4 ... Displaying Drugs Regulatory Affairs.pdf.
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