Palliative Care

Role of
Drugs Control Administration
By

Dr. Ravi Shankar IPS

Director General
Drugs Control Administration, AP
rsa2010@gmail.com, dgdca-ap@nic.in
ENSURING AVAILABILITY ACCESSIBILITY & AFFORDABILITY
OF SAFE, STANDARD & EFFICACIOUS DRUGS
 LAWS AND STATUTES ENFORCED
1. Drugs and Cosmetics Act, 1940
- To ensure the availability of safe, efficacious and standard quality medicines and safe blood.
- Drugs & Cosmetics Rules-1945
- Medical Devices Rules-2017

2. Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954

& Rules, 1955
- To prevent the ignorant and unwary from resorting to self medication with drugs or fall prey
to extravagant claims through advertisements for drugs which may cause great harm

3. Drugs (Prices Control) Order, 2013 r/w Essential Commodities Act,

1955.
- To ensure that drugs are sold at the prices fixed by NPPA

4. A.P Narcotic Drugs and Psychotropic Substances Rules, 1986. (For

limited purpose)
- Grant of licenses (NDPS-1 & NDPS-2) and transport permits for NDPS
drugs (inter and intra state)
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 Role of Drugs Control Administration

To ensure availability of :
 Standard, Safe and Efficacious medicines
 At reasonable and effordable prices.

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 Regulation of Narcotic Drugs

 Manufactured Drugs: Formulations of Narcotic Drugs for Medicinal Use includes: Morphine, Pethidine,
Fentanyl etc.
 Chapter-V of AP NDPS Rules-1986
 Retail sale of Manufactured Drugs
 Movement of Manufactured Drugs: Inter State & Intra State
 All the regulations under Drugs & Cosmetics Act-1940 and Rules-1945 for formulations also applicable
to Narcotic Drugs
 Availability of Narcotic Drugs

• Narcotics (Manufactured Drugs) are available across the state in all the Cities
• Especially in cities with more Health Care Facilities

• Licensing Procedure:
 Application submitted in Drugs Inspector Office with a fee of Rs. 50/-
 Application processed after verifying the facility of Lock & key
 License issued by Deputy Directors in Regional Offices
 To be renewed by 1st of January of every year
 Subsequently Narcotics can be purchased by obtaining Transport permit for every
consignment from Assistant Director of the District
 Dispensing

• Narcotics shall be dispensed against a written prescription (in duplicate) by a

Registered Medical Practitioner
• Copy of the prescription must be retained by the Licensee
• Details of sale and purchase to be Recorded in NDPS register
• Damaged products must be destroyed in the presence of the Drugs Inspector
only
• Details of Sale will be verified on routine basis by Drugs Control Officials
 Supply to Medical Institutions – Palliative Care

• Amendment to APNDPS Rules brought in 2009 by introducing Chapter-VA

with specific norms for Medical Institutions
• Registration of Medical Institution of Medical Institutions having more need
of Morphine by State Drugs Controller
• Quota Approval for entire at once
• Consumption as per the prescription of Oncologist only
• No need of Transport Permit for every purchase of Morphine
• Medical Institutions are exempted from other conditions of the APNDPS
Rules-1986
• Presently No medical Institution approached DCA for Registration
 Current Needs

• Fentanyl also may be permitted under Chapter-VA along with Morphine for
consumption by Medical Institutions

• Other Specialists also may be permitted to prescribe

• Awareness need to be created in Medical Fraternity & Palliative care centres

about special provisions for Medical Institutions
Thank you