Category Archives: regulatory updates

Making Markets Work for Affordable Healthcare – Policy Note

The Competition Commission of India on 28-29 August organized a technical workshop on ‘Competition Issues in the Healthcare and Pharmaceutical sector in India’, as a follow up to this workshop on 24/10/2018 the CCI issued a policy note titled ‘Making Markets Work for Affordable Healthcare’. The primary focus of this policy note is to provide and create a pro-competition market in the healthcare industry.  It has been observed that pharma/healthcare suffer with information asymmetry the note stated.

The press note enumerates various problems related to the pharma/healthcare industry (in four distinct categories) which prohibit the industry from becoming pro-competition.

Below is a summary of the issues and possible solutions discussed by the CCI under the policy note:

Role of intermediaries in drug price build up:

  1. High trade margins and closed and connected distribution channels. Further the self-regulation by trade associations contribute towards high trade margins.
  2. A larger and wider public procurement and distribution system of essential drugs can circumvent the high trading prices. Initiatives like Pradhan Mantri Jan Aushadhi Pari Yojna  are an excellent example of the same.
  3. Using electronic means of trading in drugs with appropriate safeguards would encourage transparency and spur competition in the market among all stakeholders.

Quality perception behind proliferation of branded generics:

  1. The Indian pharmaceutical market is dominated by branded generic drugs which are expensive in nature. The reason being, brand identity and the quality of these branded drugs. The note clearly states in this regards “However, it is also equally possible that the brand proliferation is to introduce artificial product differentiation in the market, offering no therapeutic difference but allowing firms to extract rents”.
  2. The note with regards to the quality of the drugs states that regulatory bodies must ensure consistent application of statutory quality control measures by each drug manufacturer.
  3. It also mentions that the problem of artificial product differentiation may be addressed through ‘a one-company-one drug-one brand name-one price’ policy.

Vertical arrangements in healthcare services:

  1. In-house pharmacies of super speciality hospitals are insulated from competition; generally the inpatients are not allowed to buy drugs or any product from outside pharmacies.
  2. The note also focuses on how all accredited (NABL) pathological labs shall maintain quality standards in terms of infrastructure, equipment, skilled manpower.
  3. Last but not the least the note states that there is no framework that ensures and governs portability of patient’s e-health records. This causes a lock-in situation for all the patients and makes it really hard for them to switch between medical service providers.

Regulation and competition:

Due to presence of various regulatory bodies at centre and state level, regulating the pharmaceutical industry has resulted in multiple standards for the same products. A mechanism under the aegis of CDSCO can be formalized to negate this issue also there should the new drug approval should be time bound.

Further the policy discusses two other issues related to the healthcare industry: (i) shortage of healthcare professionals in the country owing inter alia to high cost of medical education and (ii) inadequacy in health insurance.

Source: https://www.cci.gov.in/sites/default/files/press_release/PressRelease.pdf

 

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Insolvency and Bankruptcy Board of India (Insolvency Resolution Process for Corporate Persons) (Fourth Amendment) Regulations, 2018

The Insolvency and Bankruptcy Board of India, vide its notification dated 5 October 2018 amended the Insolvency and Bankruptcy Board of India (Insolvency Resolution Process for Corporate Persons) Regulations, 2016 by notifying the Insolvency and Bankruptcy Board of India (Insolvency Resolution Process for Corporate Persons) (Fourth Amendment) Regulations, 2018.

The key changes brought through this amendment are as follows:

  • Omitted the meaning of dissenting financial creditors as given in Regulation 2 (1) (f) of the Insolvency and Bankruptcy Board of India (Insolvency Resolution Process for Corporate Persons) Regulations, 2016.
  • Removal of the requirement under Regulation 21(3) (b), for the notice of the meeting of committee of creditors to state that the vote of the members of committee should not be taken unless all the members are present at such meeting.

Amendments in the voting process of the committee of creditors

  1. Amendment of Regulation 25 (5) has been brought to provide for the detailed voting procedure by electronic means in case a member is not present for a meeting. The amended regulations now also provide for the circulation of minutes to the authorized representatives in addition to the creditors. The authorized representative is obligated to circulate the minutes of meetings received by it, to the creditors in a class and announce the voting window at least twenty-four hours before the window opens for voting instructions and keep the voting window open for at least twelve hours.
  2. Addition of sub-regulation 1A to Regulation 26 which provides that the authorized representative shall exercise the votes either by electronic means or through electronic voting systems as per voting instructions received by him from the creditors in the class.

Resolution Plan

  1. Substitution of sub-regulation (1) of Regulation 38 which now provides that the mandatory content of the resolution plan shall provide that the amount due to operational creditors under a resolution plan must be given priority in payment over financial creditors. Earlier the provision provided for specifying the insolvency resolution process costs providing that the insolvency resolution process costs will be paid in priority to any other creditors;
  2. Omission of Regulation 39 (1) (b), the requirement of providing an undertaking by the prospective resolution applicant that he shall provide additional funds to the extent required is no longer required.
  3. Omission of sub-regulation (3A) of Regulation 39, the committee is no longer required to specify the amounts payable from resources in the contents of the resolution plan, while approving the same.
  4. Addition of regulation 39A, which provides for preservation of records. It states that the Interim Resolution Professional or the Resolution Professional shall preserve physical and electronic copy of the records relating to corporate insolvency process of the corporate debtor as per the record retention schedule that the Insolvency and Bankruptcy Board may communicate in consultation with the Insolvency Professional Agencies.

Sources

  1. https://ibbi.gov.in/webadmin/pdf/whatsnew/2018/Oct/CIRP%20Amendment-5.10.2018_2018-10-05%2023:21:24.pdf
  2. https://ibbi.gov.in/webadmin/pdf/legalframwork/2018/Aug/Insolvency%20and%20Bankrutpcy%20Code,%202016%20(31%20of%202016)%20upto%20date%20amendment%2017.08.2018_2018-08-19%2013:27:42.pdf.
  3. https://ibbi.gov.in/webadmin/pdf/legalframwork/2017/Oct/CIRP%20Regulations%20-%20after%202nd%20Amendment_2017-10-24%2017:32:27.pdf.

Enhanced disclosure requirements for Credit Rating Agencies

SEBI vide its circular dated 13 November 2018 has tightened the norms for Credit Rating Agencies (CRAs) by enhancing the levels of disclosures required to be made by the CRAs under the SEBI (Credit Rating Agencies) Regulations, 1999 (CRA Regulations). As per the recent circular, the following changes have been brought about:

  1. Under an earlier circular dated 1 November 2016, SEBI had prescribed the standard format for press releases put out by CRAs regarding rating action. Now, specific disclosures must be made in the press release;
    • with respect to rating factors where support from a parent/group/government entity is expected, the name of such entities and the rationale for such expectation to be mentioned.
    • when subsidiaries or group companies are consolidated to arrive at a rating, the names of all such companies, along with the extent of consolidation and rationale for the same to be disclosed.
  2. The above-mentioned press release must also contain a specific section on ‘Liquidity’ with parameters like liquid investments or cash balances, access to unutilised credit lines, liquidity coverage ratio, adequacy of cash flows for servicing maturing debt obligation, etc.
  3. Disclosure of any linkage to external-support for meeting near term maturing obligations must also be made by CRAs.
  4. CRAs may review their rating criteria with regard to assessment of holding companies and subsidiaries in terms of their inter-linkages, holding company’s liquidity, financial flexibility and support to the subsidiaries, etc.
  5. In monitoring of repayment schedules, CRAs to analyse the deterioration in the liquidity conditions of the issuer and also take into account any asset-liability mismatch.
  6. CRAs may treat sharp deviations in bond spreads of debt instruments vis-à-vis relevant benchmark yield as a material event.
  7. CRAs to publish their average one-year rating transition rate over a 5-year period, on their respective websites, calculated as the weighted average of transitions for each rating category, across all static pools in the 5-year period. This shall be adhered during the half-yearly internal audit of the CRAs under the CRA Regulations.
  8. CRAs to furnish data on sharp rating actions in investment grade rating category to Stock Exchanges and Depositories for disclosure on website on half-yearly basis, within 15 days from the end of the half-year (31st March/ 30th September).

Link to source:

https://www.sebi.gov.in/legal/circulars/nov-2018/guidelines-for-enhanced-disclosures-by-credit-rating-agencies-cras-_40988.html

Basic Cyber Security Framework for Primary (Urban) Cooperative Banks (UCBs)

The Reserve Bank of India (RBI) on October 19, 2018 issued a set of guidelines for Basic Cyber Security Framework for Primary (Urban) Cooperative Banks (UCBs). Such a framework was issued by the RBI as a measure to enhance security of the UCBs in light of the increasing number and impact of cyber security attacks on the financial sector including banks. [1]

  1. Board Approved Cyber Security Policy
  • All UCBs need to immediately put in place a Cyber Security policy, duly approved by their Board/Administrator, giving a framework and the strategy containing a suitable approach to check cyber threats depending on the level of complexity of business and acceptable levels of risk.
  • On completion of the process, confirmation of same within 3 months must be sent to the Department of Co-operative Bank Supervision.
  • The Cyber Security Policy should inter alia encapsulate the following concerns:
  • Preventing access of unauthorised software.
  • Network Management and Security.
  • Secure Configuration.
  • Anti-virus and Patch Management.
  • Secure mail and messaging systems.
  • The IT framework/framework must be reviewed periodically by the Board or its IT subcommittee in order to identify vulnerable areas and put in place a suitable cyber security system to address the issues after assessment.
  1. Cyber Crisis Management Plan
  • The Cyber Crisis Management plan, prepared by CERT-In (Computer Emergency Response Team – India maybe referred to by the UCBs for guidance.
  • UCBs should promptly detect any cyber intrusions (unauthorised entries) so as to respond/recover/contain impact of cyber-attacks, especially those offering services such as internet and mobile banking, RTGS/NEFT/SWIFT, credit and debit cards etc.
  1. Organizational Arrangements
  • UCBs should review the organisational arrangements so that the security concerns are brought to the notice of suitable/concerned officials to enable quick action.
  • UCBs should actively promote among their customers, vendors, service providers and other concerned parties an understanding of its cyber security objectives.
  • UCBs, as owners of customer sensitive data, should take appropriate steps in preserving the Confidentiality, Integrity and Availability of the same, irrespective of whether the data is stored/in transit within themselves or with the third party vendors; the confidentiality of such custodial information should not be compromised in any situation.
  • UCBs to put in place suitable systems and processes across the data/information lifecycle. UCBs may educate and create awareness among customers with regard to cyber security risks.
  1. Supervisory reporting framework
  • UCBs should report immediately all unusual cyber security incidents (whether they were successful or mere attempts) to Department of Co-operative Bank Supervision giving full details of the incident.
  • UCBs are advised to implement basic Cyber Security Controls and report the same to respective Regional Offices of Department of Co-operative Bank Supervision on or before March 31, 2019.

Source: http://www.rbi.org.in/scripts/NotificationUser.aspx?Id=11397&Mode=0

https://rbidocs.rbi.org.in/rdocs/content/pdfs/63NT19102018_A1.pdf

[1] http://www.rbi.org.in/scripts/NotificationUser.aspx?Id=11397&Mode=0.

Competition Act: Amendment to the Combination Regulations Seeks to Simplify the Procedures Relating to Combinations

The Competition Commission of India (“Commission”), with the main objective of simplifying the procedures relating to combinations provided under the Competition Act, 2002 (“Competition Act”), has recently amended the Competition Commission of India (Procedure in regard to the transaction of business relating to combinations) Regulations, 2011 (“Combination Regulations”). The Combination Regulations, which was first introduced on May 11, 2011 has been amended multiple times and the latest amendment to the same is the Competition Commission of India (Procedure in regard to the transaction of business relating to combinations) Amendment Regulations, 2018 (“Amendment Regulations”) which was notified on 9 October, 2018.

Some of the Key Amendments are:

The Amendment Regulations Provides Clarity on the Time Period of 210 Days for a Combination to come into Effect:

As per the Act, every combination shall come into effect only after 210 days have passed from the date when the notice regarding the combination has been given to the Commission or the Commission has passed an order in relation to the same, whichever is earlier[1]. The Combination Regulations provides for getting additional information, clarifications, rectification of defects, etc. if required. However, there was no clarity in relation to whether the time taken to get these details would be covered within the 210 days period. Now, as per the Amendment Regulations, it is clear that the time period for getting additional information, clarifications, rectifications of defects, etc. is not included in the 210 days period. This essentially means that the time taken for a combination to come into effect will now be longer even for deemed approval due to the additional time that may be taken for getting additional information, clarifications, rectifications, etc.

Withdrawal and Re-Filing of Notice

As per the Amendment Regulations, a new regulation 16A has been inserted which states that, any time prior to issuance of notice by the Commission to the parties to a combination under Section 29 (1) of the Act[2], the Commission, may on the request of the parties to the combination allow withdrawal and refiling of the notice. Also, in case of withdrawal and refiling, the fee already paid in respect of such notice will be adjusted against the fee payable in respect of the new notice, provided the new notice is given within 3 months from the date of withdrawal.

Modifications to the Combination

As per the Amendment Regulations, before the Commission forms an opinion under Section 29 (1) of the Act, the parties to the combination may offer modifications to the combination and the Commission may approve the proposed combination basis such modifications. The position before the amendment was that, only if the Commission considered it necessary, it may require the parties to file additional information or accept modification.

Modifications in response to the Notice issued by the Commission

As per regulation 25 (1) of the Combination Regulations, the Commission can propose appropriate modifications to a combination if it is of the opinion that such combination is likely to have adverse effect on competition but such adverse effect can be eliminated by suitable modifications. Now, a new regulation 25 (1A) is inserted whereby, along with the response to the notice issued by the Commission under Section 29 (1) of the Act, the parties to the combination also can offer modifications to address the concerns of the Commission. The Commission may approve the combination basis such modifications. In such a case, the additional time required to evaluate the modification shall be excluded from the period provided under sections 6 (2A), 29 (2) and 31 (11) of the Act.

Source:https://www.cci.gov.in/sites/default/files/whats_newdocument/Comb.%20Amend%20Regl.2018.pdf

[1] Section 6 (2A) of the Act

[2] As per Section 29 (1), where the Commission is of the prima facie opinion that a combination is likely to cause, or has caused an appreciable adverse effect on competition, it shall issue a notice to show cause to the parties to combination calling upon them to respond within 30 days of the receipt of the notice, as to why investigation in respect of such combination should not be conducted.

Regulatory update: Prepaid Payment Instruments (PPIs) – Guidelines on Interoperability

The Reserve Bank of India (RBI) on October 16, 2018 issued a set of guidelines for interoperability of PPIs. The guidelines are issued under Section 18 read with Section 10(2) of the Payment and Settlements Act, 2007. PPI issuers who choose to adopt interoperability shall adhere to these guidelines along with the Master Direction[1].

  1. Common requirements for achieving interoperability for wallets and cards
    • Where the PPIs are issued in form of online wallets, interoperability shall be facilitated through UPI and where PPIs is issued through a card, the cards shall be affiliated to authorised card networks. Option of interoperability has also been provided to PPI issuers operating in segment of meal, gift and mass transit system (MTS).
    • The interoperability shall be facilitated to all KYC compliant PPI account and entire acceptance infrastructure.
    • Technical Requirement: While facilitating interoperability the PPI issuer shall comply and adhere to all requirements of respective card networks and UPI, including adherence to various standards, technical requirement specific to a payment system, certification, audit and etc.
    • Further the PPI issuers will have to comply with mechanism established for reconciliation, grievance redressal and consumer protection by UPI and specific card networks.
  2. Specific Requirements for achieving interoperability through card networks
    • Card networks are allowed to integrate PPI issuers on their network. Further the non-banking PPI issuers are allowed to join card networks as members or associate members.
    • Settlement: For the purpose of settlement, Non-banking PPI issuer may directly participate in the card network or through a sponsor bank arrangement while adhering to requirements of the specific card network which it is a member of.
    • Safety and Security
  3. Non-banking PPI issuers will be issuing interoperable cards for the first time and therefore they shall make sure that the cards have an EMV chip and are PIN compliant.
  4. Banks shall ensure that while issuing new PPIs and renewing the old PPIs, the cards shall have EMV and shall be PIN compliant.
  • If a PPI issuer in the meal segment intends to facilitate interoperability, it shall also issue EMV chip and PIN compliant cards, whereas it is not compulsory for PPI issuers in the gift cards and MTS segment to have EMV chip and PIN.
  1. Specific requirements for achieving interoperability through UPI
    • PPI issuers will operate as payment system providers (PSP) in the UPI network. National Payment Corporation of India (NPCI) will provide all the PPI issuers, including non-banking PPI issuers a platform for linking their respective PPI holders/users to the platform to facilitate interoperability. The platform issued will use UPI to provide such Interoperability.
    • The PPI issuers as PSPs are only allowed to integrate their PPI holders/users and shall not on board PPI holders/users of other PPI issuers or customers of banks.
    • Any interoperable transaction will be approved as per the credentials of an individual’s online wallet before the same transaction reaches UPI network.
    • Settlement: Non-banking PPI issuer can directly settle a payment though a sponsor bank. Non-banking PPI issuers shall adhere to the requirements of sponsor bank in the UPI network and shall also comply with requirements stipulated by NPCI.

Source: https://www.rbi.org.in/Scripts/BS_ViewMasDirections.aspx?id=11142

[1] https://www.rbi.org.in/Scripts/BS_ViewMasDirections.aspx?id=11142

Telecom regulatory Authority of India (TRAI) – Certificate of compliance

TRAI vide its direction no F. No 123-1/2018 NSL-II dated 7 September 2018 has withdrawn the Direction No. 101-41/2006-MN dated 21 August 2006 which had directed all the telecom service providers to furnish a certificate of compliance to TRAI by 31 July every year in respect of the following:

  1. Direction dated 28 October to all Universal Access Service Providers (UASPs) and M/s Bharat Sanchar Nigam Limited (BSNL) regarding posting of information to Universal Service Obligation (USO) related activities on their website;
  2. Direction dated 6 January 2005 to all service providers on opening of allotted codes;
  3. Direction dated 16 June 2004 to all the Cellular Mobile Service Providers (CMSPs) on auto-roaming services to all pre-paid subscribers; and
  4. Direction dated 11 July  2002 to all CMSPs to include standard terms and conditions in all tariff-plans for pre-paid cards.

A committee was formed comprising of officers of TRAI as representatives of the telecom service providers and associations, to identify the infructuous/redundant regulations and amendments and it was observed that the obligations of the above cited directions are no longer required.

Available at: https://www.trai.gov.in/sites/default/files/Direction07092018_0.pdf