Central Information Commission
Adla Satya Narayan Rao vs Directorate Of General Of Health ... on 15 November, 2018
CENTRAL INFORMATION COMMISSION
Baba Gang Nath Marg, Munirka,
New Delhi-110067
F. No.CIC/DTGHS/A/2017/118250
Date of Hearing : 30.08.2018
Date of Interim Decision : 30.08.2018
Date of Final Decision : 14.11.2018
Appellant/Complainant : Adla Satya Narayan Rao
Through: Sh. Robin R David and Sh.
Shashank Dixit - Advocate
Respondent : PIO
Nodal Officer-RTI Cell
Directorate General of Health
Service,
Through:-Jayant Kumar, Yogesh
Shelar
2. Bharat Serums & Vaccines Ltd.
Through: Mr. Charudatta Sawant,
Dr. Anita Samagod, Mr.Baijnath
Tiwari
Information Commissioner : Shri Yashovardhan Azad
Relevant facts emerging from appeal:
RTI application filed on : 13.08.2016
PIO replied on : -
First Appeal filed on : 07.10.2016
First Appellate Order on : 10.01.2017
2nd Appeal/complaint received on : 20.03.2017
Information soughtand background of the case:
Vide RTI application dated 13.08.2016, the appellant sought information copy of the complete file alongwith all the documents pertaining to the application by Bharat Serums & Vaccines Ltd. requesting for Market Authorization Registration for the purpose of manufacturing and sale of "Rhoclone" in India. CPIO, Jayant Kumar vide letter dated 13.08.2016 stated that sought information calls under the ambit of Section 8(1)(d) of RTI Act, 2005 which read as "Information including commercial confidence trade secrets or intellectual property, the disclosure of which would harm the competitive position of third party unless a competent authority is satisfied larger public interest warrant the disclosure of such information.
Dissatisfied with refusal of information, the appellant filed first appeal. FAA vide letter dated 10.01.2017 observed that the matter also falls under the ambit of 8(1)(e) of RTI Act, 2005 which categorically states that -information available to a person in his fiduciary relationship, unless the competent authority is satisfied that the larger public interest warrants the disclosure of such information is exempted from disclosure of information. For the compliance of same, this office had issued a third party notice under section 11(1) of RTI Act, 2005.
Feeling aggrieved over denial of information, the appellant approached the Commission.
Facts emerging during the course of hearing:
The appellant's counsel opened his arguments narrating that information about market authorisation for this particular drug has been sough since the drug Rhoclone is a very crucial one, administered to pregnant women with RH(+) blood group. The Respondent's claim for exemption from disclosure of information under Section 8(1)(d) and Section 8(1)(e) of the RTI Act, were strongly objected by the appellant and reliance placed on a catena of judgements. The appellant's counsel further pointed out that the respondent had neither resorted to section 8 nor Section 11 of the RTI Act, while outrightly denying the information. The various judgements cited by the appellant include the celebrated judgments in the case of RBI & Ors. vs. Jayantilal Mistry & Ors.[AIR 2016 SC 1];Bhagat Singh vs. Chief Information Commissioner &Ors.[146(2008)DLT385]. Concluding his averments, the counsel for the appellant emphasised that information was sought about the drug, in order to ensure the safety and efficacy of its usage in the nation. He explained that the drug Rhoclone contains component which are not made out of human plasma and therefore fails to conform with the standards set by the Indian PharmaCopoeia and WHO guidelines. Hence, it is of utmost importance to ascertain that the drug so marketed and being administered to pregnant women conforms to the safety norms and does not pose any health hazard as such.
Rebuttal of appellant's contentions were commenced by the representative for the third party viz. M/s Bharat Serums & Vaccines Ltd, since they possess expert knowledge about the product in question. It was articulated by the company's representative that the product Rhoclone has been introduced in market in the year 2014 by their company, after arduous research and analysis and checking all efficacy and safety measures and conducting research for nine years. There has been no complaints received for the product/drug in question, ever since its launch in market and today this drug has captured lion's share of market in this specific arena. It has further been informed by the Third party's representative that the testing of the drug for reviewing its standards is under process, to conform the drug to the standards and mandates of the Indian Pharma Copoeia Commission. Resisting to disclosure of complete information about the documentation that transpired before the market authorisation of Rhoclone, the representative for the company has stated that the documentation contains minutest details of the research and technology used in designing/manufacturing of the drug. Years of labour and research have gone into developing of the drug which are contained in the documents submitted before the DGHS. However, disclosure of this information will result in complete destruction of competitive position and technological expertise and supremacy achieved by the Bharat Serums, through years of research and efforts. The Respondent further clarified that indeed Rhoclone does not use human plasma alone because it is a more advanced and developed version of the earlier products being used. Thus this drug has been so developed so as to provide safer and more effective remedy preventing the Rho-D negative women from encountering any problem during pregnancy and at childbirth. The Respondent from DGHS sought time to submit effective response to the averments of the Appellant in details about the various checks and verifications before approving the drug Rhoclone from being marketed all over the country.
Interim Decision: 30.08.2018 In the light of the intricate and detailed averments of the parties, the Commission is of the considered opinion that appropriate written submissions from the Respondent DGHS and from the Third Party is warranted to arrive at a substantive conclusion in this case. Accordingly, all three parties are directed to exchange their respective pleadings and contentions within 10.09.2018. Commission shall take its view in the matter after exchange of all relevant submissions.
Order reserved.
Final Decision: 14.11.2018
1. The Commission is in receipt of a communication dated 08.09.2018 from the Third Party viz. M/s Bharat Serums & Vaccines Ltd. comprising of technical and legal submissions as follows:
I. The Technical write up submitted by the Third party include the following:
"Bharat Serums and Vaccine Ltd. (BSVL) is one of the leading biopharmaceutical companies in India, specialized in development and marketing of biologics and biotechnology products. Overview of the development of Rhoclone (Monoclonal Anti D) at BSVL:
Anti-Rho D immunoglobulin (Rhoclone) manufactured by Bharat Serums and Vaccines Ltd, India) is a lifesaving drug and administered to Rh negative women delivering Rh positive infants it is indicated to prevent Rho D negative women from forming antibodies to foetal Rh positive red blood cells that may pass into the maternal blood during child birth, abortion or other sensitizing events.
Our in-house development of monoclonal Anti-D was initiated in 2003. Traditional method involving EBV transformation of human B- cells was employed to generate hybridomas secreting Anti-D. Several hundreds of clones were screened for biological activity and other properties before the clones were selected for clinical development. The final hybridoma clone for clinical application was selected and the cell banks were established and characterized for safety as per ICH guidelines at Charles River Laboratory, USA.
The cells producing Anti-D immunoglobulin are grown in bioreactor using micro carrier beads. The antibody secreted by the cells is purified by a series of chromatographic methods followed by nano filtration to give the final purified bulk API. The purified bulk API bulk is further formulated to give the final product-Rhoclone. The major advantages of Rhoclone as compared to Anti-D immunoglobulin products derived from human blood are as follows:-
1. Monoclonal anti-D immunoglobulin is safer than the blood derived immunoglobulin products. No fear of contamination with disease causing viruses such as HIV, Hepatitis B and Hepatitis C as in human blood derived products.
2. Batch-to-batch consistency as Rhoclone is produced by stable hybridoma cells resulting in a homogeneous product.
3. Since monoclonal antibody production is in-vitro it provides essentially unlimited supply.
4. Highly specific and efficient at low concentrations of total protein.
A lot of efforts have been put by BSV into the development of Rhoclone, which has been extensively characterized in terms of its physicochemical and biological properties. The manufacturing process for bulk drug substance is well established using the hybridoma cell line. The product has also been evaluated in pre-clinical and clinical studies for safety and efficacy. There were no deaths, serious or significant AEs during the conduct of the clinical studies. There were no spontaneous ADR or SUSAR reported for Rhoclone during the reporting interval. The safety and efficacy of the product is thus well-established.
In addition, we have gone through the formal approval process in India, involving Institutional Ethics, Review Committee on Genetic Manipulation (RCGM), and Drug Controller General of India (DCGI), along with testing for approval at the Indian Government labs such as Kasauli and NIB.
Since the introduction of Rhoclone in 2010, BSV has sold 3.85 million units of Rhocline (300 mcg) and 0.5 million units of Rhoclone (150 mcg) with no adverse events reported to date. It is also registered in 20 countries and exported to more than 39 countries."
II. The relevant extracts of legal submissions from the Third Party are as follows:
(a) ....................................................................
(b) ..........................The current Application falls squarely within the exemption granted under Section 8(1)(d) as the Application in question clearly seeks information which is covered under the terms "commercial confidence", "trade secrets" or "intellectual property".
(c) ........................................................................
(d) ........................................................................
(e) The disclosure of the information sought is of proprietary information protected under law, the disclosure of which would cause irreversible injury and harm to BSVL.
(f) ...........................................................................
(g) ..............................In the present case, it has not been articulated and established as to whose pecuniary interests or legal rights are affected. The Applicant's failure in this regard goes to the very root of the matter and renders his Application unsustainable in law.
(h) ..........................................................................
(i) The issue ostensibly raised as public interest, relating to public health as to the safety, reliability or therapeutic efficacy of the product are issues which squarely fall in the domain of the administrators of the Drugs & Cosmetics Act. Factually, no such issue has arisen in the last 14 years of the product being in the market. In any event, even if there was any such issue, it is squarely and exclusively in the domain of the DGCI. The RTI Act cannot be used as a basis to transgress in the domain of a regulatory authority such as the DGCI, and, hold DGCI accountable through some extra legislative mechanism beyond the Drugs & Cosmetics Act.
(j) The product in question is a lifesaving drug which has saved thousands of lives in India. The entire proceeding in question seems to be a covert attempt to undermine the path breaking impact of an Indian manufactured lifesaving drug. The Application is unsustainable in law and seems tainted by extraneous commercial considerations of potential competitors.
13. In this regard, BSVL places reliance on an order passed by this Hon'ble Commission in the case of Ajay Chadha v. Dr. R.S. Agarwal {CIC/DS/A/2013/001664+1668}, in which this Hon'ble Commission has observed that in order to attract the provisions of the Section 8(1)(d) of the RTI Act, the critical test to be applied is whether the disclosure of the information sought would harm the competitive position of the third party and the protection afforded by the Section 8(1)(d) of the RTI Act cannot be lifted or disturbed unless the appellant is able to justify how such disclosure would be in 'larger public interest'.."
..........................................................................................................
17. In relation to this contention, BSVL places reliance on the judgment of the Hon'ble Supreme Court in the case of Central Board of Secondary Education & Anr. V. Aditya Bandopadhyay & Ors, in which the Apex Court examined the scope and ambit of the word "fiduciary relationship"
...."
The Third Party has emphatically stated that the information sought by the appellant is exempt under Section 8 (1)(d) and (e) of the RTI Act while placing reliance on a catena of judgments from the Supreme Court and the Delhi High Court. They have further stated that the appellant has failed to establish any larger public interest which necessitates such disclosure of information. Reliance has been placed on the decision in the case of B. Singh vs. Union of India wherein the Hon'ble Supreme Court has dealt with the exact purport of the term "larger public interest"
and held that information which is interesting as gratifying curiosity or love of information or amusement cannot be treated to be in larger public interest. Public Interest is to be understood as something which affects the legal rights or liabilities of the masses.
2. The Respondent viz. Directorate General of Health Services have also submitted a written statement dated 10.09.2018, pursuant to the directions of the Commission. The Respondent has explained that denial of information to the appellant was based entirely on objection expressed by the Third Party, in response to the notice sent to the Third Party under Section 11(1) of the RTI Act. The legal and technical submissions submitted by the Third Party and discussed above have been relied upon by the Respondent to justify the denial of information.
The Commission has examined all of the above submissions received from the Respondent as well as the detailed averments made by the Third Party. Submissions as discussed above have dealt with each and every contention and apprehension raised by the appellant so far. The Commission finds the contentions of the Third Party self explanatory and require no reiteration to be affirmed as such. The exemption as claimed by the Third Party invoking Section 8 (1)(d) of the RTI Act are found reasonable and justified. Furthermore, such information as sought by the appellant are submitted with the Respondents to carry out the necessary regulatory checks. Such information as are customarily placed before the Regulatory authority obviously contains all technical and commercial data in a threadbare manner, which cannot be expected to be disseminated among public in general, in order to protect the competitive or financial position of the business concerned. Moreover, as has been pointed out by the answering Respondents, the appellant has failed to establish any case of overwhelming public interest. The effect of the drug in question Rhoclone on general public health is a matter already under the scrutiny of the DGCI and within the purview of the Drugs and Cosmetics Act, appellant cannot be expected to transgress into the domain which is already earmarked for a specific regulatory authority.
In the light of the aforesaid facts as discussed hereinabove, there appears no justification in dissemination of information as sought by the appellant. The appeal is accordingly dismissed.
The case is closed and file be consigned to Record Room.
(Yashovardhan Azad) Information Commissioner Authenticated true copy. Additional copies of orders shall be supplied against application and payment of the charges prescribed under the Act to the CPIO of this Commission.
(R.P. Grover) Designated Officer