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SPIC seeks PM's intervention to denotify 'illegal' notification mandating jt inspections by CDSCO & SLAs for grant of licenses to industry
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Ramesh Shankar, Mumbai
October 30 , 2018
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The SME Pharma Industries Confederation (SPIC) has sought Prime Minister Narendra Modi's intervention to denotify the 'illegal' notification GSR 1337(E) dated 27.10.2017 mandating joint inspections by Central Drugs Standards and Control Organisation (CDSCO) and State Licensing Authorities (SLAs)for grant of licenses to industry as 'this is an unconstitutional means adopted by CDSCO to shut down pharma SMEs'.
In a letter to the PM, SPIC secretary general Jagdeep Singh alleged that this notification has created a furore because there is reliable information that CDSCO has taken this route to shut down 60 per cent pharma SMEs after divesting the state governments of exclusive powers to regulate manufacture and sale of drugs as per Chapter 4 of the Drugs Act 1940. Emboldened by said notification some CDSCO inspectors are already conducting even solo raids in factories and lifting samples against which the State Licensing Authorities have objected in writing to the DCGI.
Notifications have been issued under the wrong presumption that Drugs Act was covered under Entry 19 of the Concurrent List of the Constitution which reads: Drugs and Poisons, subject to the provision of entry 59 of List 1 (cultivation, manufacture and sale for Export, of opium. This entry pertains only to opioid drugs (derived from opium & covered under NDPS Act) and does not cover non-opioid drugs, Singh said.
Delving deep into the background, Singh in his letter mentioned that Drugs & Cosmetics Act 1940 was a pre-independence Act covering import of drugs and control of manufacture, sale & distribution of drugs separately. The former was exclusively under the ambit of Federal Government and latter under under the Provincial governments. Centre could legislate to amend executive powers of the States for manufacture and sale provided the respective states passed a Resolution under section 103 of Government of India Act 1935. Such a resolution was passed by Provincial Assemblies and the Drugs Act bill 1940 was framed wherein Chapter III for control of import of drugs was assigned to the Central Government and Chapter IV for control of manufacture & sales of drugs was assigned to the States.
This Bill was implemented w.e.f. 10 April 1940 and was later adopted as such under the Constitution of India w.e.f. 26 January, 1950. Powers of State & Central Governments remain defined and unchanged after transit into Indian Constitution. Similarly, the instrument passed by the provincial governments u/s 103 of GOI Act 1935 remains unchanged with transit into Constitution of India by virtue of Presidential order through Article 372(2) of the constitution in paragraph 15 & 19 of the Adaptation of Laws Order 1950.
Therefore, manufacture and sale of drugs remains a State Subject covered under State List (list II) of the Constitution of India. It was wrongly presumed to be the in the Concurrent List and amendments made by Central Government, Singh further said in his letter.
Inspections are a part of licensing which fall under the exclusive domain of state governments to regulate manufacture and sale. Powers to inspect the manufacturing units jointly by the CDSCO vide GSR 1337(E) are unconstitutional. States cannot be divested of their powers. Certain manufacturing Associations have already represented to the PM that, inter alia, Inspector Raj is only being enacted to close down pharma SMEs and extortions by CDSCO are unaffordable under a stringent GST regime. CDSCO may confine itself to imports, etc.
“Union Government and Drug Technical Advisory Board (DTAB) may kindly restore Constitutional decorum by striking down the illegitimate Notification and restrain illegitimate raids by CDSCO”, the SPIC demanded in its letter.
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