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Schedule X

✓ Contains list of narcotic drugs and psychotropic substance.

✓ Have a warning mentioned on a label 'Schedule X drug'-Warning to be sold on retail on prescription of a RMP only.

✓ The label will also have a symbol 'NR' in red & conspicuously displayed on the top left corner.

✓ After dispensing the drug the pharmacist must Stamp & retain the prescription for 2 years.

✓ Maintain & record purchase & sale of the drug and preserve it for a period of 2 years from the date of transactions.

✓ All the regulations of Schedule H apply. The drugs must be kept under lock and key.

Examples of few drugs under schedule X:- Phencyclidine, Secobarbital, Amobarbital, Amphetamines, Glutethimide, Methylphenidate, etc.

Schedule Y

This Schedule includes requirements and guidelines for permission to import and/ or manufacture of new drugs for sale or to undertake clinical trials

It include:

✓ Application for permission

✓ Clinical trial - Under that

1. Approval for trial

2. Responsibilities of sponsor, investigator, Ethics Committee

3. Phases I, II, III, IV

✓ Studies in special population like Geriatric, Pediatric and Pregnant/ Nursing women

✓ Post Marketing Surveillance

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