Manufacturers And Marketers Fail To Comply With Rule 84AB Of DnC Act Due To Technical Snag

Chennai, 12 Jan 2021:

The Central government’s repeated attempts to ensure compliance of Rule 84AB of the Drugs and Cosmetics Rules 1945 by manufacturers of licensed facilities and marketers of approved formulations are getting failed time and again since 2019.

According to the Union health ministry, uploading information about licensed manufacturing facilities and approved formulations on SUGAM portal is to comply with the provisions of Rule 84AB of the D&C Rules.

Finding that there is no comprehensive database of the manufacturing facilities and the products approved by SLAs in India, the central government amended the D&C Rules 1945 on 10.01.2019 by incorporating Rule 84AB which mandates uploading the data, pertaining to the licences granted, on the SUGAM portal. The information uploaded is also required to be verified by the concerned drugs controllers.

It is learnt that, so far neither the state drug controllers could succeed in their efforts with the industry nor the manufacturers could comply with the government order as directed by the state regulators.

It is learnt that despite the central government puts enormous pressure on the state DCs to impress upon the manufacturers for uploading their details, most of the manufacturing companies in the country have so far not uploaded their information on the portal even when the drugs control administrations continue to push the industry. The industry cites the reason for the inability to upload the data is that the portal has some technical snag which prevents them from uploading.

Meanwhile, accusing the Central government of mounting pressure upon the manufacturers for uploading the data on the portal, the president of the Punjab Drug Manufacturers Association (PDMA), Jagdeep Singh has alleged that the Union government has no legal right to check the details of the state government licensed facilities. He has written to the state drugs controller that the right to inspect a licensed facility is vested with a drug inspector appointed by a state government. But a letter received by the health secretary of Punjab from the office of the joint secretary of the central health department, states that non-compliance with the provisions relating to uploading of data on SUGAM portal will attract Section 18B of the D&C Act and penal provisions under Section 28A which carries imprisonment upto one year or fine upto one thousand rupees or both.

As per section 18B, every license holder should keep and maintain the records, registers and documents pertaining to the licences and furnish them, to any officer or authority exercising any power or discharging any function under the act, the information required by the officer or authority for carrying out the purposes of the act.

Singh further argues that the data mandated under Section 18B of the act can only be sought and examined by a drug inspector appointed by a state government. He is the officer authorized to inspect and initiate action under Section 22 (1) (cc) and section 22 (1) (cca) which empower the drug inspector to inspect a facility. Those who are pushing the matter with state DCs to examine the data on the portal do not possess the powers of a drug inspector appointed by a state government.

Therefore, the Rule 84AB is itself a violative of sections 22 (1) (cc) and 22 (1) (cca), and any kind of examination of data by a person other than a drug inspector is violation of provisions of the D&C act, argues the PDMA president.

While talking to Pharmabiz, Singh said the attempt of the central government to collect data from manufacturers licensed by the state government is also an attempt to divest the state governments of their powers. Because the central government cannot assume the role of a drug inspector who is responsible for examination of the records, registers and documents maintained under sections 22 (1) (cc) and 22 (1) (cca). He is also the responsible official to initiate penal action under section 28A.

However, he further said while attempting to upload data on the portal, it is mentioned that the privacy of the manufacturers is not guaranteed and the terms and conditions are liable to change. He says that this condition cannot be accepted as it is against the law of the land. The data of the manufacturers are not for public view, hence they cannot be forced to accept a variable which is unknown. Jagdeep Singh said because of this reason the manufacturers of Punjab have withdrawn from uploading data on the SUGAM portal.

Meanwhile, the recently joined DC of Punjab did not want to comment on the issue. But M Sivabalan, the drugs controller of Tamil Nadu said the process is going on, but the manufacturers face problems in uploading details. “The portal is not user-friendly, but one by one they are rectifying it”, he added.

When contacted the president of Kerala Pharmaceutical Manufacturers Association (KPMA) president, Purushothaman Namputhiri, he said some technical snags prevent them from uploading information.Pharmabiz