Central Information Commission
Nagella Raveendra Babu vs Ministry Of Health & Family Welfare on 29 January, 2025
Author: Heeralal Samariya
Bench: Heeralal Samariya
के न्द्रीय सूचना आयोग
Central Information Commission
बाबा गंगनाथ मागग, मुननरका
Baba Gangnath Marg, Munirka
नई दिल्ली, New Delhi - 110067
नितीय अपील संख्या / Second Appeal No. CIC/MH&FW/A/2023/645507
Shri Nagella Raveendra Babu ... अपीलकताग/Appellant
VERSUS/बनाम
PIO, Ministry of Health & Family Welfare, ...प्रनतवािीगण /Respondent
Central Drugs Standard Control Organisation
Date of Hearing : 27.01.2025
Date of Decision : 27.01.2025
Chief Information Commissioner : Shri Heeralal Samariya
Relevant facts emerging from appeal:
RTI application filed on : 06.07.2023
PIO replied on : 04.08.2023
First Appeal filed on : 25.08.2023
First Appellate Order on : 18.09.2023
2ndAppeal/complaint received on : 21.09.2023
Information soughtand background of the case:
The Appellant filed an RTI application dated 06.07.2023 seeking the following information:-
"What are the measures taken to control spurious drugs manufacturing, selling and distribution in India. With the advances in technology, medicines are being sold online. What are the means by which citizens can compliant about spurious drugs to authority. Is there any online complaint mechanism exists in the country? If online complaint mechanism exists, what measures have been taken to create awareness to the citizens. What is the turn around timeline for the complaint address mechanism. If online complaint mechanism does not exists, who is responsible for establishing this system. Please provide details/escalate this to the concerned department. Does Indiamart (https://www.indiamart.com/) authorized to sell medicines in India? Through this online route people are being cheated with spurious drugs."
reproduced verbatim The CPIO vide letter dated 04.08.2023 replied as under:-
"Reply License for manufacture, sale and distribution in the country is regulated by the State Licensing Authorities appointed by the respective State Government are empowered to take action in case of any violation comes under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder. Further, CDSCO Page 1 of 4 and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:
1. On 17-11-2022, the Drugs Rules, 1945 were amended vide G.5.R. 823(E) which has come into force on 1st of August, 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule HZ, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication. The stored data shall include the following particulars, namely: (i) unique product identification code, (ii) proper and generic name of the drug, (i) brand name, (iv) name and address of the manufacturer, (v) batch number, (vi) date of manufacturing. (vii) date of expiry, and (viii) Manufacturing licence number.
2. On 18.01.2022, the Drugs Rules, 1945 were amended vide G.5.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the minimum particulars including Unique product identification code, Batch No, MFG date, Exp. Date etc.
3. The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 το provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
4. States/UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal
5. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been significantly increased in last 10 years.
6. To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.
7. The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.
8. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority."
Dissatisfied with the response received from the CPIO, the Appellant filed a First Appeal dated 25.08.2023. The FAA, Joint Drugs Controller vide order dated 18.09.2023 held as under:-
"Various Notification/Office Memorandum(s) (OMs)/Order(s)/Circular(s)/Alert(s) issued by the CDSCO and for complaint etc the official address/Email ID(s) of CDSCO including the Drugs and Cosmetics Act, 1940 and Rules made thereunder etc. are available in the official website of CDSCO at www.cdsco.gov.in. Further, clarification/interpretation/opinion does not come under the definition of "information" under Section 2(f) of RTI Act, 2005."Page 2 of 4
Aggrieved and dissatisfied, the Appellant approached the Commission with the instant Second Appeal.
Facts emerging in Course of Hearing:
A written submission dated 21.01.2025 has been received from CPIO, Central Drugs Standard Control Organisation reiterating the above facts referring to the replies already sent to the Respondent.
Hearing was scheduled after giving prior notice to both the parties.
Appellant: Present Respondent: Shri Ashok Yadav-ADC and Shri Mahesh Kr. Saini were present during hearing.
At the outset, the Appellant expressed dissatisfaction with the response provided by the Respondent. Responding to the Appellant's contentions, the Respondent referred to the FAA's order stating that the Appellant had been duly informed that Notification/Office Memorandum(s) (OMs)/Order(s)/Circular(s)/Alert(s) issued by the CDSCO and for complaint etc. the official address/Email ID(s) of CDSCO are available in the official website of CDSCO at www.cdsco.gov.in.. It was also informed by the Respondent that license for manufacture, sale and distribution of drugs in the country is regulated by the State Licensing Authorities appointed by the respective State Government, empowered to take action in case of violation. The Appellant was also informed about the regulatory measures taken by the Ministry of Health and Family Welfare to ensure the quality of medicines in the country. Thus it was recommended that the Appellant may either file his complaint on the website or on the CPGRAM portal for redressal of his grievance.
Decision Upon perusal of records of the case and after hearing averments of the parties, the Commission is of the considered opinion that information available on record with the public authority as defined under Section 2(f) of the RTI Act has been duly furnished to the Appellant, in terms of the provisions of the RTI Act. The Respondent has also recommended possible avenues for redressal of grievance of the Appellant, since addressing grievance does not form part of the mandate under the RTI Act. In the given circumstances, since appropriate information in terms of provisions of the RTI Act has already been provided by the Respondent, no further intervention is warranted in this case, under the RTI Act.
The appeal is disposed off accordingly.
Heeralal Samariya (हीरालाल सामररया) Chief Information Commissioner (मुख्य सूचना आयुक्त) Authenticated true copy (अनिप्रमानणत सत्यानपत प्रनत) S. K. Chitkara (एस. के . नचटकारा) Dy. Registrar (उप-पंजीयक) Page 3 of 4 011-26186535 Page 4 of 4 Recomendation(s) to PA under section 25(5) of the RTI Act, 2005:-
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