Attempt all the problems.
Section-A
problem1) describe briefly regulatory system in India to govern pharmaceutical manufacturing, testing sales and development of new drugs in India.
problem2) What are the purpose of Drug prices control order in India? What is the impact of drug price control order on Indian Pharmaceutical industry and what strategies drug companies adopt to reduce its impact?
problem3) What policies or programmes must pharma companies adopt to raise expectation that personnel from lowest chemist in R&D to the salesperson to the regional director for marketing to regulatory and disclosures and compliance, made decision in a ethical way?
problem4) What are the kinds of licenses and other legal agreements used to facilitate clinical traits, branding, promotion and distribution of pharma product?
Section-B
Case Study
A company xxx started by unqualified person decided to venture into pharmaceutical business thinking it is safe, sound and highly profitable. Company managed to get the sales tax number and wholesale licence number and started trading of pharmaceuticals. It made good profits and promoter thought, to increase profits further it must start manufacturing of drugs. It obtains a sick pharmaceutical company closed for several years in an auction and started manufacturing of drugs immediately on taking possession.
The company made 3 drug formulations which started selling well. The claims for the three drugs were
1. Drug A : To treat and cure AIDS
2. Drug B : Cures Cancer
3. Drug C : Cures Diabetes
Company also decided to manufacture a drug to cure blindness and paid Rs.500 each to 10 beggars outside a temple and started doing clinical studies to create some data.
Some health activists came to know about activities of the company and reported matter to Drug control department which conducted raids and seized all the goods and sealed premises of the company and prosecuted the owner of the company.
problems
problem1) In your opinion, what are the contravention’s of various Drugs Acts, the company xxx made during its course of operations? List the relevant Drug Acts also.
problem2) What must have been the right procedure for the company to do it different activities in terms of seeking necessary approvals/permissions?
problem3) What are the likely penalties under each Act, the promoter of the company could be given because of the various contraventions?