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The Drug Controller General of India (DCGI) plays a vital role in regulating the pharmaceutical industry. While regulatory bodies are designed to ensure that the industry operates smoothly and safely, there have been instances where the bureaucracy has been accused of pushing the industry to accept unfavorable practices. This article delves into the DCGI’s role in industry regulation and the need for greater accountability, with a specific focus on a recent case involving Azithromycin Amine.

Detailed Analysis:

i. Purpose of Administration: Every administration is established to facilitate the application of laws and regulations in a user-friendly manner, allowing industries to prosper. The key function of regulatory bodies is to ensure the law is upheld while promoting the growth of the industry.

ii. Respect for the Law: It is crucial for regulatory bodies to command respect by adhering to the law and not resorting to bulldozing the industry into accepting practices that are against its interests. Respect cannot be demanded or earned through force.

iii. Challenges in the Pharmaceutical Industry: Despite adopting international standards for manufacturing and product registrations, the Indian pharmaceutical industry has faced challenges, as exemplified by the Ranbaxy case and recent cough syrup-related deaths, which garnered international attention.

iv. Discrepancies in Regulatory Oversight: Discrepancies are evident when comparing FDA inspections in India with those conducted by other FDA authorities worldwide. There seems to be a gap in expectations and a lack of emphasis on competence and knowledge within the Indian regulatory framework.

v. The Case of Azithromycin Amine: The article focuses on the case of Azithromycin Amine (AA), which has faced import clearance issues at Mumbai ports. Despite not being a bulk drug and not subject to the Drugs & Cosmetics Act, 1940, the product has been held up due to adamant regulatory attitudes.

vi. Azithromycin Amine’s Nature: Azithromycin Amine serves as an intermediate for the manufacture of Azithromycin Dihydrate/Monohydrate and is not intended for direct therapeutic use. It is classified as a chemical intermediate, exempt from drug manufacturing licensing in India.

vii. ITC Code Classification: Azithromycin Amine is categorized under ITCHS 29419090 as a precursor for Azithromycin Dihydrate/Monohydrate. Though the ITC code covers antibiotics, it’s essential to recognize Azithromycin Amine’s status as an intermediate.

DCGI and Industry Regulation

viii. Chinese Manufacturer’s Claims: The case encounters challenges due to claims made by a Chinese manufacturer’s website regarding the use of Azithromycin Amine in medical treatment. The ADC at JNCH has cited these claims to support the need for import clearance NOCs.

ix. Challenges to the Misrepresentation: The article argues that a chemical cannot be deemed a drug solely based on a manufacturer’s website claims. Recognition as a drug requires efficacy and safety studies, verification by FDA authorities, and alignment with pharmacopeia standards.

x. Need for Accountability: The article stresses the importance of accountability and reasoned decision-making within the DCGI. It calls for the DCGI to resolve disputes and clarify the status of substances rather than leaving such decisions to individual port authorities.

xi. Systemic Corruption Concerns: The piece touches upon the issue of systemic corruption, indicating that it is challenging to combat corruption when the industry fears repercussions and regulatory authorities wield significant power without accountability.

The Role of Regulatory Bodies in Industry Oversight:

The pharmaceutical industry is heavily regulated to ensure the safety and efficacy of drugs and medical products. Regulatory bodies, like the DCGI, are entrusted with the responsibility of enforcing these regulations and ensuring that businesses in the pharmaceutical sector adhere to these standards.

The primary goal of such regulatory bodies is to strike a balance between facilitating industry growth and safeguarding public health. This involves the issuance of licenses, certifications, and approvals, as well as conducting inspections to ensure that manufacturing processes comply with the prescribed standards.

However, the story is not always straightforward, and sometimes regulatory bodies can face criticism for their practices. In recent years, the Indian pharmaceutical industry has come under the spotlight for various reasons, including quality control issues, malpractices, and alleged corruption within the regulatory framework.

One of the notable cases that has raised concerns is the prolonged and controversial ordeal involving Azithromycin Amine. This case not only highlights the challenges faced by the pharmaceutical industry but also underscores the need for greater transparency, accountability, and adherence to international standards within the regulatory framework.

The Azithromycin Amine Case:

Azithromycin Amine, often referred to as AA, serves as an intermediate product in the manufacture of Azithromycin Dihydrate/Monohydrate. It is essential to understand that Azithromycin Amine is not intended for direct therapeutic use, making it a chemical intermediate. This classification is crucial as it places Azithromycin Amine outside the realm of drug manufacturing licenses under the Drugs & Cosmetics Act, 1940. Furthermore, it is categorized under the ITCHS code 29419090, as it serves as a precursor for the manufacture of Azithromycin Dihydrate/Monohydrate. While this code covers antibiotics, it is vital to recognize that Azithromycin Amine’s role is that of an intermediate product.

The controversy surrounding Azithromycin Amine arises from claims made by a Chinese manufacturer’s website regarding the product’s use in the treatment of medical conditions. These claims have been cited by the ADC at JNCH as a basis for requiring import clearance NOCs. The argument made by regulatory authorities is that because the product is associated with therapeutic claims, it should be treated as a drug and subject to the relevant regulations.

However, the pharmaceutical industry argues that a mere claim on a manufacturer’s website should not be sufficient to categorize a chemical intermediate as a drug. The industry insists that before any chemical entity is recognized as a drug, it must undergo thorough efficacy and safety studies. These studies should then be subject to verification by the relevant regulatory authorities before the product can be officially recognized as a drug.

The Importance of Accountability and Reasoned Decision-Making:

The Azithromycin Amine case highlights a crucial aspect of regulatory oversight—accountability. The pharmaceutical industry is a knowledge-based sector where precision and adherence to international standards are paramount. Decisions made by regulatory authorities should be based on comprehensive assessments, rigorous scientific evaluations, and alignment with internationally accepted norms.

In this case, the regulatory authorities are called upon to address the discrepancy between the claims made by a manufacturer’s website and the actual nature of Azithromycin Amine. Rather than leaving such decisions to individual port authorities or being swayed by unsubstantiated claims, it is essential for the regulatory body, in this case, the DCGI, to intervene.

The DCGI should issue reasoned, speaking orders, and clarify the status of substances in cases where there is ambiguity. Such reasoned decisions should be based on scientific evidence, industry standards, and adherence to international norms. This approach would not only resolve disputes but also instill confidence in the industry and the public.

Challenges of Systemic Corruption:

The pharmaceutical industry is not the only sector that faces challenges in the regulatory landscape. Systemic corruption is a concern that plagues various industries and can have far-reaching consequences. In the case of the pharmaceutical sector, corruption can lead to unfavorable practices, compromising the safety and efficacy of drugs and medical products.

One of the challenges of addressing systemic corruption is the fear of repercussions. The industry often hesitates to expose corruption within regulatory bodies due to concerns about potential consequences. Regulatory authorities, with their significant power, can create a climate of fear that hinders transparency and accountability.

Systemic corruption is a deeply entrenched issue that requires a concerted effort to address. It is essential to establish mechanisms for reporting and addressing corruption within regulatory bodies, ensuring that industry players can come forward without fear of retaliation.


The Azithromycin Amine case serves as a poignant example of the challenges and discrepancies within the Indian pharmaceutical industry’s regulatory framework. There is a pressing need for greater accountability, transparency, and adherence to international standards within the regulatory bodies like the DCGI. Only by addressing these issues can the industry truly prosper while ensuring the safety and well-being of consumers.

Accountability and reasoned decision-making should be the cornerstones of regulatory bodies, such as the DCGI, to maintain trust and integrity within the pharmaceutical sector. By focusing on scientific evidence, industry standards, and international norms, regulatory authorities can foster an environment that encourages innovation and growth while safeguarding the public interest.

Systemic corruption, another formidable challenge, must be tackled with determination. It is crucial to create mechanisms that allow industry players to report corruption without fear of retaliation, ensuring that regulatory bodies are held to the highest standards of transparency and ethics.

In summary, the Azithromycin Amine case underscores the need for a reevaluation of the regulatory landscape within the Indian pharmaceutical industry. By addressing the issues discussed in this article, we can foster an environment of trust, transparency, and accountability that benefits not only the industry but also the health and well-being of the public.


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July 2024