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Civil society organizations have urged the Drugs Controller General of India (DCGI) to make new Drugs, Cosmetics & Medical Devices (DC&MD) Act harmonized, rational, transparent, predictable and free from conflict of interest.
A committee was set up by the Union Health Ministry to frame the new Act de-novo under the chairmanship of DCGI on August 27, 2021.
The DCGI had recently organized a consultation with stakeholders from civil society on the revision of the Drugs and Cosmetics Act.
The meet was attended by representatives from Third World Network, Low Cost Standard Therapeutics (LOCOST), All India Drug Action Network (AIDAN), Organizations for Rare Diseases India, among others.
S Srinivasan, co-founder of LOCOST, who attended the consultation said, “At about the year 1970, the total turnover of the domestic pharma industry of India stood at Rs. 300 crore and today it has reached Rs. 1.5 lakh crore, an equal amount for exports. Over the years the health ministry has introduced changes in the Drugs and Cosmetics Act and Rules to tackle the emerging regulatory challenges with the concomitant rapid expansion of the pharma market. Attempts at piecemeal regulation of the emerging challenges over the years have led to certain contradictions and lack of harmonization between various aspects of the amendments introduced in the Act.”
For instance, Section 26A of the D & C Act has empowered CDSCO to ban drugs. DCGI can ban drugs without consultation of DTAB but the pharma companies affected by the ban have argued the ban as illegal because DTAB has not been consulted. There is no requirement in the Act that DTAB has to be consulted in as much as DTAB is not consulted while approving the drugs. Nevertheless, the issue has caused sufficient confusion in the courts delaying the implementation of the ban. There needs to be a clear statement on the issue in the proposed revised version of the Act.
As another example needing revision, Srinivasan cited Schedule J of the Drugs and Cosmetics Act and Rules. The said Schedule contains a list of diseases and ailments which a drug may not claim, or purport to, prevent or cure. Under Section 106 of the Drugs and Cosmetics Act, 1940, a drug cannot make claims to treat or prevent any of the diseases or reform the conditions listed such as blindness, AIDS, Parkinson, Hernia, Glaucoma, Hydrocele, jaundice, Myocardial infarction etc, he said, pointing out that most of the diseases mentioned in the list can be treated now. Hence there is a need to update the list.\
Yet another area that needs to be clarified is that approval of a drug needs to be independent of its patent status.
He said “The patent status and approval of drugs should not be linked. Irrespective of a drug’s patent status, marketing approval for a drug should be provided to generic companies, so that drugs can be introduced in the domestic market after expiry of patent or compulsory licensing issued by the government.” Issues if any raised regarding patents are outside the scope of the Act and the health ministry and must continue to be.
He added only rationality, therapeutic efficacy and evidence-based scientific scrutiny of drugs should be part of the approval process rather than considerations like whether a drug is under patent or is likely to be patented.
Another area is ethical marketing of an approved drug – the current version of the Drugs and Cosmetics Act does not have anything to say on this most important issue. This needs to change urgently, Srinivasan opined.
He said there are many such issues which need to be looked into and therefore the broad consultative process initiated by the DCGI and involving various stakeholders is welcome. At the same time the new version of the Act must have greater predictability, rationality and transparency as its guiding principles.
While welcoming the move, KM Gopakumar, legal advisor for Third World Network said, “The Drugs and Cosmetics Act 1940 is a product of its time. The new Drugs, Cosmetics, Medical Devices Act which is being framed should be based on good governance and transparency and free from conflict of interest. There should be a mechanism in the Act to avoid conflict of interest in various committees set up by CDSCO.”
Gopakumar further said submissions made by the firms while seeking drug approval are kept as trade secret but there are circumstances-- pandemic wherein generic production of drugs is required. Trade secrets should be waived during such circumstances to facilitate availability of drugs, he said.
The process of drug approval, especially approval of new drug entities needs to be made more transparent in the new Act. The approval of NCE should be separated like an orange book of US FDA which contains approved drug products with therapeutic equivalence evaluations, said Gopakumar.
He also emphasized the need to make biosimilar guidelines more evidence-based and do away with phase 3 clinical trial in the existing guidelines.
Malini Aisola, co-convenor, AIDAN said “In new Act, there must be specific statutory provisions for providing public information like the rationale for approvals, evidence & data on the basis of which decisions are taken etc.”
Currently, there is a disturbing lack of transparency and non-availability of information that ought to be shared publicly. CDSCO has given very little regard to sharing of information with the public and also to patient safety, she said.
The distinction between Restricted Emergency Use (REU) Approval and Full Approval remains a mystery to this day. It is impossible to know how the REU permissions granted fall short of full licensure under the current statutory provisions, said Aisola.
“There has been a relaxation of data requirements and various concessions made in the grant of approvals for Covid-19 drugs and vaccines keeping in mind the situation of pandemic. However, no clarity has been provided on what distinguishes the approvals for “restricted use in emergency situation” from a full approval and where this is provided for in the law,” she pointed out.
The CDSCO has also made a mockery of the law during this period. For example, “clinical trial mode” was cooked up even though there is no such terminology in the Drugs and Cosmetics Act, 1940 and Rules, 1945 or the New Drugs and Clinical Trials Rules, 2019.
There are several instances of faulty Covid-19 drug approvals. Two particularly egregious examples are of favipiravir and itolizumab REU authorisations. Favipiravir received approval in June 2020 when its phase 3 trial was still ongoing.
Subsequently, the phase 3 trial failed in meeting its primary endpoint. The regulator ought to have reviewed the license based on the recent scientific evidence. Yet, this went on to become a blockbuster drug with the highest sales in the last year.
CDSCO granted REU permission to itolizumab based on its phase II trial on July 10, 2020 and exempted it from phase 3 trial. Following these multiple inconsistencies in data and irregularities in the conduct of the trial emerged, which call into question the existing approval.
The National Covid-19 Task Force did not recommend either of the drugs for inclusion in the national clinical management guidelines for Covid-19.
While the discussion is taking place for framing of a new law, noncompliance of existing laws remains a serious issue, she rued.
Talking about medical devices, she stressed the need to strengthen regulatory systems for ensuring product safety through adequate testing and laying down of norms for clinical trials and related investigations particularly for high-risk devices and implants; limit the over-reliance on foreign regulatory authorities for granting licenses in India; strengthening post-marketing monitoring & reporting of performance of devices; and statutory provisions for compensation of victims of faulty implants.
She suggested that it would be more appropriate for the new Act, to regulate marketing and promotion practices for pharmaceuticals and medical devices to ensure ethical behaviour on the part of manufacturers, traders & prescribers. Till date the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) is a voluntary code which the DOP is unable to convert into a legally binding instrument and therefore unethical practices are continuing unabated to the detriment of consumers.
The substance of the Magic Remedies Act should also be brought under the new Act, she added.
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