Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on May 9, 2022 by The Health Master
Q1:When was DPCO order 2013 implemented ?
Ans. Drugs (Prices Control) Order, 2013 (DPCO 2013) is issued under Section 3 of Essential Commodities Act, 1955 vide S.O no. 1221(E) dated 15.05.2013 and is effective from 15-05-2013.
To download, click below links:
Drugs-Price-Control-Amendment-Order-2019
Drugs-Price-Control-Order-2013
Drugs-Price-Control-Order-1995
Q2: What is the status of old DPCO order 1995?
Ans. DPCO, 2013 is notified in supersession of DPCO, 1995, except as respect to the things done or omitted to be done before such supersession.
Q3: Who fixes the ceiling price of the drug?
Ans: The Govt. shall fix and notify the ceiling price of the scheduled drug under para 14 of the DPCO order 2013. However, Govt. has empowered National Pharmaceutical Pricing Authority for the same.
Q4: Which are the drugs for which govt. can fix and notify the prices?
Ans. Prices are fixed of the drugs included in Schedule I. However, Government may fix ceiling or retail price of any drug in extra-ordinary circumstances, in public interest.
Q5: What are the scheduled drugs?
Ans Govt. of India has notified National List of Essential Medicines (NLEM) which comes under first schedule I of DPCO Order 2013 and this list is updated time to time.
To download the NLEM, click below links:
Report-of-the-Core-Committee-for-revision-of-NLEM-2015
National-List-of-Essential-Medicines (NLEM)-2015
National-List-of-Essential-Medicines (NLEM)-2011
National-List-of-Essential-Medicines-NLEM-2003
Q6: How many drugs have been notified by the Govt. under first schedule I of DPCO, 2013?
Ans: There are about 540 formulations.
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Q7: Is DPCO 2013 applicable to Ayurvedic and Homeopathic medicine also ?
Ans No. It is not applicable to Ayurvedic, Siddha, Unani, Homoeopathic drugs.
Q8: What price of the scheduled drugs manufacturers can print on label of the said drug ?
Ans. Price fixed by NPPA + local tax applicable = MRP (maximum retail price) of the drug.
Q9: If the manufacturer labels price exceeding that notified then what is liability under DPCO, 2013
Ans. The manufacturer, importer is liable for recovery of overcharged amount with accrued interest and / or penalty as per Para 14 (2) or Para 23 of DPCO.
Q10: What do you mean by new drug under DPCO, 2013?
Ans: As defined under Para 2 (u) new drug is a formulation containing a drug of dosage form or strength other than that listed in Schedule I or by is a combination of drug with Scheduled drug, launched by a manufacturer already manufacturing scheduled formulation. Such manufacturer shall apply for prior price approval in Form-1 as specified under Form Schedule-1 (as per Para no. 15 of DPCO, 2013).
Q11: What are Non-scheduled drugs?
Ans: Non-scheduled drugs are those drugs which do not come under Schedule I of DPCO, 2013.
Q12: Who revises the ceiling price of scheduled formulations?
Ans: Government (NPPA) revises price as per para no. 16 of DPCO, 2013 prior to 1st April of every year.
Q13: Who amends the list of scheduled formulation?
Ans: Government can amend as per para no. 17 of DPCO order 2013.
Q14: Whether govt. can fix the ceiling price of the drug other than scheduled drugs under certain circumstances.
Ans: Yes, as per para no. 19 of DPCO, 2013 may fix ceiling or retail price of any drug in extra-ordinary circumstances, in public interest.
To read all FAQs of the author, click here
Q15: Whether prices of non-scheduled are monitored?
Ans: Yes, as per para 20 of DPCO, 2013, the manufacturer cannot increase the retail price of non scheduled formulation by more than 10% of MRP during the preceding 12 months.
Q16: Whether every price of a drug, scheduled or non-scheduled should be displayed.
Ans: Yes, as per para no. 25 of DPCO Order, 2013, MRP of formulation shall be displayed with the words “Maximum Retail Price” preceding it and the words ‘inclusive of all taxes’ succeeding it.
Q17: What is the contravention if a person sales a drug above more than MRP?
Ans: Violation of Para 26, DPCO, order 2013.
Q18: What is liability of offenders for contravention of the provisions under any para of DPCO, 2013?
Ans: The offenders are liable for recovery of overcharged amount with interest, penalty as per provisions under DPCO, 2013 as well as action under section 7 of the Essential Commodities Act, 1955.
To read or download the EC Act 1955, click here
Q19: Whether medical devices are covered under DPCO, Order 2013?
Ans: Yes. As per SO no. 1232 (E) dated 31.03.2020, all medical devices are regulated under DPCO, 2013.
To download the notification SO no. 1232 (E) dated 31.03.2020, click here
Q20: Which are the medical devices whose price is fixed by the Govt.?
Ans: Cardiac Stent, Drug Eluting stent, Condom and Intra Uterine Devices are scheduled drugs and their price is fixed by NPPA.
Q21: In which section, the manufacturers shall maintain the sale record?
Ans: Manufacturers shall maintain the sale record as per Para no. 29 of DPCO 2013.
Q22: Whether is it mandatory to issue price list of each drug?
Ans: Yes, it is mandatory to issue price list by the manufacturer, importer in Form V under Schedule II, whether it is scheduled or non-scheduled drug.
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