INTRODUCTION

The pharmaceutical and life sciences industry has been at the center of public discussion this year like never before due to the COVID-19 pandemic. The role of the industry has been crucial not only in developing potential treatments or vaccines for COVID-19 but also in ensuring that drug supplies for other disorders remain uninterrupted. The drug regulator has also acted quickly and decisively during this pandemic to ensure that pharmaceutical companies get the support they need to be able to maintain a steady supply of medicines.

In this pharma wrap, we have summarized the key regulatory developments that took place over 2020.

HEALTH MINISTRY PROPOSES TO AMEND INDIA’S PRIMARY DRUG PROMOTION LEGISLATION

The Ministry of Health and Family Welfare (“Health Ministry”) on February 03, 2020, published a draft amendment proposing to amend the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 (“DMRA”) – the primary legislation governing the advertisements in India (“Proposed Amendment”).¹

Broadly, the Proposed Amendment (i) alters the definition of ‘advertisements’ to specifically include advertisements made over electronic media, the internet or websites, (ii) provides a provision under which the Ayurvedic, Siddha and Unani Technical Advisory Board (the advisory board on the various systems of Indian medicine) may be consulted with respect to advertisement of Ayurveda, Siddha and Unani drugs, and (iii) increases the penalties for the contravention of the DMRA. More significantly, the Proposed Amendment expands the list of diseases, disorders or conditions that a drug may not claim to diagnose, cure, mitigate, treat or prevent (“Scheduled Condition”).

Currently, the DMRA consists 54 Scheduled Conditions. The Proposed Amendment expands this list of 79 disorders by essentially amalgamating the existing schedule to the DMRA with the disorders listed in Schedule J of the Drugs and Cosmetics Rules, 1945 (“D&C Rules”) – a set of rules framed under India’s primary drug control legislation, the Drugs and Cosmetics Act, 1940 (“D&C Act”). Schedule J to the D&C Rules specifies a separate list of disorders that a drug may not claim to diagnose, cure, mitigate, treat or prevent. However, while Schedule J of D&C Rules is limited to claims made on the drug labels, the DMRA applies to advertisements in general.

Overall, the contribution of the Proposed Amendment is limited to widening the list of disorders in the schedule to the DMRA. The proposed revision in the definition of ‘advertisement’, though significant, is essentially clarificatory in nature and does not alter the existing legal position. This is because the existing definition of ‘advertisement’ already covers promotional campaigns made over electronic media, social networking sites and websites.

HEALTH MINISTRY ISSUES NOTIFICATION TO MAKE MARKETERS OF DRUGS RESPONSIBLE FOR QUALITY OF DRUGS AND REGULATORY COMPLIANCES

The Health Ministry issued a notification on February 11, 2020 amending the D&C Rules such that entities marketing a drug are responsible for the quality of the drug and for carrying out regulatory compliances in respect of the drug (“Marketer Amendment”).² The Amendment will come into force on March 01, 2021.

Under the Marketer Amendment, a ‘marketer’ is any person who adopts a drug manufactured by another manufacturer for sale and distribution, by affixing or labelling their name on the drug. The Marketer Amendment also requires manufacturers and marketers to enter into an agreement for marketing the drug as a pre-condition to such activity. Once such an agreement is in place, the name of the marketer is required to be displayed on the label of the drug. In case of defect in the drug or any regulatory non-compliance in respect of the drug, both the manufacturer and the marketer will share the liability.

Currently, the D&C Rules hold only the manufacturer of the drug liable for any defects in the drug or for gaps in compliance in respect of such drug and not the company marketing the drug. As a result, many pharmaceutical companies have entered into contract manufacturing agreements with third parties such that the pharmaceutical company only markets the drug and the contract manufacturer is solely responsible for the quality of the drug and other regulatory compliances. The Marketer Amendment aims to incentivize pharmaceutical companies to ensure that contract manufacturers engaged by the pharmaceutical companies are compliant with the D&C Rules.

INDIAN GOVERNMENT AMENDS REGULATION FOR BLOOD BANKS

The Health Ministry has amended the D&C Rules to tighten existing regulation for blood banks and streamline the blood donation process by way of notification dated March 11, 2020 (“Blood Bank Amendment”).³

Broadly, the Blood Bank Amendment renames blood banks to blood centres, revises the licensing procedure for blood centres, stipulates new qualification requirements for technicians working at blood centres, and specifies norms regarding who can and cannot donate blood. Under the Blood Bank Amendment, licenses for operating blood centres can be granted and renewed only if such blood centre is approved by the Blood Transfusion Council of the State or Union Territory as per procedure laid down by the National Blood Transfusion Council. The previous set of rules did not involve the National Blood Transfusion Council in the licensing process.

The Blood Bank Amendment also specifies eligibility criteria for persons donating blood, referred to as voluntary donors. For instance, under the Blood Bank Amendment, persons under the age of 18 and over the age of 65, or persons with a hemoglobin level of less than 12.5g/dL, or a person who is HIV positive or suffers from Hepatitis B or Hepatitis C is not eligible to become a voluntary donor. The Amendment also specifically accounts for disabled persons and prisoners by stating that prisoners may not donate blood, while disabled persons should donate blood only if consent can be clearly communicated.

The Blood Bank Amendment brings uniformity to blood donation procedure across India by stipulating a nation-wide criteria for licensing of blood centres and also by specifying eligibility criteria for voluntary blood donors. However, the industry experts are skeptical on whether tighter regulation will be effective as the issue at the ground-level is that blood centres operate without a license and revamped regulation may not prove sufficient to tackle the issue without adequate enforcement.

HEALTH MINISTRY PERMITS DOORSTEP DELIVERY OF DRUGS IN LIGHT OF COVID-19 PANDEMIC

The Health Ministry has issued a notification under the D&C Act to permit retail pharmacies to deliver drugs directly to patients’ homes in light of the COVID-19 pandemic (“Doorstep Delivery Notification”).⁴ Notably, the Doorstep Delivery Notification was made under Section 26B of the D&C Act, which permits the Central Government to regulate the manufacture, sale or distribution of a drug in public interest e.g. in emergencies arising due to epidemic or natural calamities.

Broadly, the Doorstep Delivery Notification permits retail pharmacies who have already obtained a retail sale license under the D&C Rules to deliver drugs directly to the consumer’s doorstep against prescriptions received over email. The email address of the licensee (the retail pharmacy in this case) is required to be registered with the drug controller before prescriptions can be accepted over email. However, certain categories of antibiotics and psychotropic substances (specified in Schedule H1 and X to the D&C Rules respectively) have been specifically excluded from the purview of the Doorstep Delivery Notification. Further, to prevent patients from filling the same prescription multiple times, the Doorstep Delivery Notification states that for prescriptions for chronic conditions can only be filled if they are presented to the retail pharmacy within 30 days from the date of prescription and within 7 days in case of acute conditions.

Prior to the Doorstep Delivery Notification, digital prescriptions were not recognized under the D&C Rules and there was some ambiguity over whether such a prescription would be considered valid. Further, home delivery models were also difficult to execute under the D&C Rules as the rules require that drugs should be dispensed directly by a registered pharmacist to the patient or the caretaker. It is currently unclear how long the Doorstep Delivery Notification would be in effect and whether similar home delivery models would be permitted once the COVID-19 pandemic subsides.

DRUG REGULATOR PROVIDES RELAXATIONS ON REGULATORY COMPLIANCE IN LIGHT OF COVID-19 PANDEMIC.

The Central Drugs Standard Control Organisation (“CDSCO”) – India’s apex drug regulator – issued the following public notices relaxing compliance requirements under the D&C Act.

• Public notice on April 23, 2020 exempting applicants for medical device import license from submitting notarized/apostilled documents (“Import Relaxation”)⁵;

• Public Notice dated May 01, 2020 extending the validity of the Good Manufacturing Practice (“GMP”) Certificate expiring between March 2020 and August 2020 by another six months (“GMP Relaxation”)⁶;

• Notification dated July 27, 2020 under Section 26B of the D&C Act extending the validity of the registration certificate granted to foreign drug manufacturers seeking to export drugs into India for the purposes of sale for a period of six months (“RC Notification”)⁷; and

• Notification dated November 26, 2020 under Section 26B of the D&C Act extending the validity of the import license granted to importers of drugs for the purposes of sale for a period of six months (“Drug Import Notification”).⁸

We have covered the background and rationale behind each relaxation below.

Import Relaxation

Under the Medical Device Rules, 2017 (“MDR”) – a set of rules framed under the D&C Act to regulate the clinical investigation, manufacture, import and sale of medical devices – importers of medical devices are required to make an application to the CDSCO to obtain an import license prior to importing medical devices into India. As part of the application for the import license, the applicant is required to notarize and apostille certain documents. The Import Relaxation gives applicants the option of submitting these documents after self-attestation along with an undertaking that the applicant will provide the notarized/apostilled documents within four months or after the ‘normalisation of the situation’, whichever is earlier. The CDSCO may grant an import license on a provisional basis based on the self-attested documents if the application as a whole is in order.

A subsequent public notice on August 31, 2020 extended the duration of the Import Relaxation by another four months until the end of 2020.⁹

GMP Relaxation

The CDSCO issues a Certificate of Pharmaceutical Product (“CoPP”) under the WHO-GMP certification scheme for the purpose of registration of Indian pharmaceutical products in foreign countries so that Indian companies can export their drugs. The CoPP certificates granted are valid for a period of three years. The GMP Relaxation extends this period by six more months from the date of expiry for CoPPs expiring between March 2020 and August 2020 to maintain continuity of essential activities in the pharmaceutical industry.

RC Notification

The RC Notification was issued in response to representations made by pharmaceutical companies whose registration certificates were set to expire soon. The RC Notification aims to prevent adverse impact on the supply of drugs in light of the COVID-19 pandemic.

To avail the exemption granted by the RC Notification, registration certificate holders would be required to apply for a fresh registration certificate prior to the expiry of the existing one. Once the application has been made, the existing registration certificate will be valid either until the expiry of six months from July 27, 2020 or until a decision is made on the application for grant of a fresh registration certificate.

To import a drug for the purposes of sale/distribution, the CDSCO grants a registration certificate to the foreign manufacturer of the drug and a corresponding import license to the India-based importer. Both a valid registration certificate and an import license are pre-requisites for importing drugs into India.

Drug Import Notification

The Drug Import Notification was issued in response to representations made by pharmaceutical companies whose import licenses were set to expire soon. The Drug Import Notification aims to prevent adverse impact on the supply of drugs in light of the COVID-19 pandemic.

To avail the exemption granted by the Drug Import Notification, import license holders would be required to apply for an import license prior to the expiry of the existing one. Once the application has been made, the existing import license will be valid either until the expiry of six months from November 26, 2020 or until a decision is made on the application for grant of a fresh import license.

The relaxations provide a welcome measure to ensure the continuity of business in these tough times.

DRUG REGULATOR OUTLINES MECHANISM FOR EXPEDITED APPROVAL FOR COVID-19 VACCINES.

The CDSCO has issued various notices and guidelines to expedite the approval of a COVID-19 vaccine as follows:

• Notice dated March 19, 2020 stating that companies who have COVID-19 vaccines under development may directly approach the Drugs Controller General of India (“DCGI”) – India’s apex drug controller and head of the CDSCO – through the public relations office to seek guidance on regulatory pathway and for expedited review and approval (“Vaccine Notice”).¹⁰

• An office memorandum dated May 26, 2020 (“Vaccine OM”) outlining a rapid response regulatory framework for an expedited approval process for COVID-19 vaccines with a checklist for data required as part of an application to conduct pre-clinical toxicity studies in respect of a COVID-19 vaccine.¹¹

• Draft Regulatory Guidelines for Development of Vaccines with Special Consideration for COVID-19 Vaccine dated September 21, 2020 (“Draft Guidelines”) containing detailed guidance in respect of study design and trial protocol to assist persons conducting clinical trials for COVID-19 vaccines.¹²

The Vaccine Notice is a preliminary notice issued at the start of the pandemic signaling the CDSCO’s intention to expedite review and approval for a COVID-19 vaccine. The Vaccine OM provides slightly more detailed guidance with two means through which the approval of a COVID-19 vaccine may be expedited. Firstly, the Vaccine OM states that pre-clinical trial data generated abroad may be considered as part of the application to conduct clinical trials made under the New Drugs and Clinical Trial Rules, 2019 (“CT Rules”) (a set of rules to regulate clinical trials framed the D&C Act). Secondly, the Office Memorandum states that clinical trial data generated outside India may be used to provide an abbreviated pathway for COVID-19 vaccine “based on scientific rational and level of completeness of data in human trials in addition to satisfactory preclinical data”.

The Draft Guidelines are in the nature of technical guidance for conducting clinical trials in respect of a COVID-19 vaccine and do not provide direct guidance on the regulatory pathway or timelines for approval.

The CDSCO is already empowered under the CT Rules to provide for an accelerated process of approving a drug based on the severity, rarity and prevalence of the condition/disorder the drug claims to mitigate or treat. The notices and guidelines clarify that the CDSCO would be permitted to use these powers in respect of COVID-19 vaccines. It should be noted, however, that each application for clinical trial/approval of a COVID-19 vaccine would be considered on a case-by-case basis and that the notices or guidelines do not bind the CDSCO to providing an abbreviated pathway for the approval of every COVID-19 vaccine. Nonetheless, it is a welcome clarification to India’s clinical trial rules and may be helpful in ensuring that a vaccine for COVID-19 is available in India around the same time that it is launched in other countries.

HEALTH MINISTRY RELEASES DRAFT RULES TO AMEND CLINICAL TRIAL REGULATION PERMITTING IMPORT /MANUFACTURE OF UNAPPROVED DRUGS FOR COMPASSIONATE USE

The Health Ministry has published a set of draft rules to amend the CT Rules permitting hospitals and medical institutions to import or have manufactured certain unapproved drugs for treatment “patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need” (“Draft CT Amendment”).¹³ The hospital/medical institution may import or have manufactured the unapproved drug after obtaining a permission from the CDSCO to this effect provided the unapproved drug is undergoing Phase-III clinical trials either in India or in any other country. The hospital/medical institution importing the drug, or the manufacturer engaged by the hospital/medical institution would be required to comply with certain obligations e.g. not selling the drug in the open market and maintaining records of import/manufacture.

Presently, the D&C Act permits patients to import small quantities of drugs for personal use and hospitals/medical institutions to import drugs which have been approved in other countries. There is no provision for importing drugs which have not been approved in any other country. If notified and brought into force, the Draft CT Amendment would bridge this gap and permit patients suffering from life-threatening diseases to undergo experimental treatment.

HEALTH MINISTRY EXEMPTS PERSONS FROM OBTAINING A LICENSE TO SELL HAND SANITIZERS

The Health Ministry has issued a notification on July 27, 2020 under Section 26B of the D&C Act exempting persons from the requirement to obtain a sale license to engage in the sale of hand sanitizers (“Hand Sanitizer Sale Notification”).¹⁴ The Notification was issued to ensure the availability of hand sanitizers in light of the COVID-19 pandemic. The CDSCO had also issued a notification on March 18, 2020 requesting state drug controllers to process applications for manufacturing hand sanitizers within a period of three working days.¹⁵

Hand sanitizers are regulated as drugs under the D&C Act and consequently may only be manufactured and sold under and in accordance with a manufacture/sale license. As a result, prior to the Hand Sanitizer Sale Notification, sellers of hand sanitizers were required to (i) obtain a license to sell hand sanitizers from the CDSCO, and (ii) comply with conditions of the sale license e.g. maintaining adequate records. While the above requirements to obtain a sale license have now been suspended, the Hand Sanitizer Sale Notification does require sellers to ensure that hand sanitizer is not sold if the product is past its ‘Date of Expiry of Potency’ as indicated on the label.

CONCLUSION

As can be seen from this year’s wrap most regulatory developments in the pharma sector have been focused around the COVID-19 pandemic. The other pattern that emerges is that the majority of the regulatory updates were through public notices and office memorandums rather than notifications in the Official Gazette. Further, many notifications issued were under Section 26B of the D&C Act which empowers the CDSCO to control the regulate or restrict the manufacture of a drug in public interest. Both these routes are considerably quicker than amending the law for a short period of time and demonstrate the regulator’s responsiveness to concerns raised by stakeholders.

In 2021, we expect the focus to slightly shift away from COVID-19 related regulatory measures towards more general regulatory changes. These may include finalizing proposed amendments to the DMRA and the CT Rules as well taking actions against marketers of drugs in case of issues with drug quality as envisaged under the Marketer Amendment.

¹ Draft of Proposed Amendment, available at: https://main.mohfw.gov.in/sites/default/files/Draft%20of%20the%20Drugs%20and%20Magic%20Remedies.pdf

² Marketer Amendment, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU1OA==

³ Blood Bank Amendment, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc2MQ

⁴ Doorstep Delivery Notification, available at http://egazette.nic.in/WriteReadData/2020/218928.pdf.

⁵ Import Relaxation, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg4NQ

⁶ GMP Relaxation, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg5OA

⁷ RC Notification, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjMyOQ==

⁸ Drug Import Notification, available at: http://egazette.nic.in/WriteReadData/2020/223363.pdf

⁹ Public notice extending the import relaxation, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQyOQ==

¹⁰ Vaccine Notice, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc2OQ==

¹¹ Vaccine OM, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk1NA==

¹² Draft Guidelines, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk1NA s

¹³ Draft CT Amendment, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk3Mw

¹⁴ Hand Sanitizer Sale Notification, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjMzMA==

¹⁵ Hand Sanitizer Manufacture Notification, available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc4Ng==