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- 03 Apr 2021, 16:24
#4721
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
✓ 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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