Is the Drugs and Cosmetics Act, 1940 obsolete now? - The Daily Guardian
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Is the Drugs and Cosmetics Act, 1940 obsolete now?

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Punjab police bust drug cartel, 1 held with 2.51 lakh pharma opioids

With the dawn of 18th Century and the Second Industrial revolution at the doorstep, the first Indian Pharmaceutical Company was established by Dr. P. C. Ray in 1901. It was christened the name Bengal Chemical & Pharmaceutical Works Ltd. and initially began its operations at Kolkata’s Maniktala.

It was the first Indian venture, which sold Medical Equipment and presented ‘herbal’ drugs to the Indian Market, while countering the British Influence within the industry. Several individuals followed suit and even during the National Movement, Pharma companies were coming up and the home-grown brands were at the forefront of making drugs and selling them.

Gradually, the Indian Pharma Market skyrocketed with several Brand name drugs and generics entering the Marketplace being sold in large quantities. However, due to such a large number of dealings, in order to cut down on costs and maximize profits, large scale adulteration of prescription and non-prescription drugs began, widely affecting the consumers.

Further, the shortage of medicines and medical equipment at the hospital aggravated the problems. With this scenario at-hand, the British rolled out the Drugs and Cosmetics Act in 1940 with the objective of legalizing the production, distribution, sale of pharmaceuticals and cosmetics. It is one of the earliest Acts, which are still in-force today.

Today, as India is among the top exporters of Generic drugs as well as Covid-19 vaccines around the world, it is evident that India has come a long way from selling herbs to creating and exporting life-saving generics. The question arises that whether this Act, being of colonial-era, has been rendered obsolete even after several amendments or not?

PROVISIONS OF THE DRUGS AND COSMETICS ACT

Since the Act’s main vision was to ensure that all drugs and cosmetics made available in India are reliable, suitable, and up to spec in regard to quality. The Act was enacted in the whole of India. In its attempt to regulate the Medical Industry, defined various terms such as ‘Drugs’, ‘Government Analyst’, ‘Cosmetics’ and relative jargons in a clear and succinct way.

The term ‘Drug’ has been defined in several ways, so as to remove the ambiguity and confusion as to what constitutes as a Drug. According to the Section-3, a drug is:

“all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes”

However, for better understanding it has also been defined like this:

“Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals”

Here, this Act also clears the air regarding the Generics and Brand-Name Drugs, but what exactly is a Generic Drug?

Supposedly, a Company made the Drug ‘A’ for curing HIV. It would be a major relief for all the Patients suffering from this vicious disease. However, due to high costs, the Patients of an underdeveloped or even a developing country are not able to afford the Medicine.

So, this is where the Generic steps in. Each medicine is made of chemical compounds, in specific quantities and release timings. These compounds could be available in any Laboratory; however, the formula of the Medicine is not available. So, on requesting the Originator Company for the formula, the same can be given by them to Generic Manufacturers.

Generic Manufacturers create the duplicate of the Medicine in bulk and sell them at affordable costs, such that the Patients can relieve themselves. This arrangement is one of the major ways how countries manage for medicines which are not available to them. However, in the pursuit of Profit and the lack of ethics, Generics often fail to perform inside the body or worse; show countereffects which can be fatal to the Patients.

Moreover, the Act has taken cognizance of this issue and prescribed ‘Standards of Quality’, that the drug complies with the standards, I.e., the quality control tests set out by the ‘The Central Drugs Laboratory’. The latter is the headed by a director and is empowered by the Act to set the benchmark quality.

While, at the administrative level, The Drugs Technical Advisory Board is formed consisting of senior-most directors of Government Medical Bodies, Presidents of MCI, several other officials who are in charge of Drug Control and the DCGI. It advises the Government on technical Matters arising from the administration of this Act. Similarly, the Act goes an extra mile with the Cosmetics as well, with defining a cosmetic as any item or substance that is poured, rubbed, sprinkled, sprayed, or applied to a person in any way with the intention of cleansing, beautifying, boosting attractiveness, or changing appearance.

Moreover, the Spurious and Misbranded cosmetics are also considered with ‘to-the-point’ criterions such as: –

• if it contains a color which

is not prescribed

• if it is not labelled in the

prescribed manner

The act also lays down punitive measures for offenders. In situations of import, Section 13 outlines the consequences in terms of maximum jail time and fines for failure to comply with any of the Act’s cosmetics regulations or standards. The Act’s Section 27A addresses penalties for violating the manufacture and selling rules. Any cosmetic that violates Section 17-C should be punished with a term of imprisonment that may last up to three years and a fine as well.

GLASS IN THE TEST TUBE

While the Act received sweeping powers to safeguard its integrity, it lacked a proper framework or a spine to support and execute its paper prowess. Despite the proper definitions, the Act still is vulnerable and criticized for its ineffectiveness on the ground.

In 2018, the cobalt-chromium ions from Johnson & Johnson’s Pinnacle hip implant was discovered to be leaking into the body. This has caused major health issues, such as metal poisoning of the blood, incapacitating pain, and organ damage. Johnson and Johnson compensated US patients who got the faulty implants, while, in India, the goliath has contested governmental directives to reimburse 4,700 people who had hip replacement surgery, and suffered heavily due to their faulty product. As a result, Johnson & Johnson took advantage of this bridge.

The Second Schedule to the Drugs and Cosmetics Act recognizes legally binding standards, but it only applies to pharmacopoeias, I.e., the guide-book for identification of the compounds, for drugs, which means there are no standards for medical devices and no way to prosecute a manufacturer of substandard medical devices, even if it causes harm to patients.

Although the Drugs and Cosmetics Act does contain a penal provision for the manufacture of substandard drugs, it cannot be used to punish manufacturers of substandard medical devices. This creates a vacuum and is a major enforceability snag. However, one major factor plaguing the act is despite the fact that the selling of subpar medications is already illegal, most drug producers get away with it thanks to lax enforcement, lack of political will and lack of cooperation.

Also, when this Act was formed in 1940, the medical equipment was not as advanced as it is in today’s time, hence leaving another gap to be filled by amendments.

More crucially, as compared to pharmaceuticals, medical devices are by their very nature much harder to standardize.

The proposed approach leaves Indian authorities without any means of holding producers of subpar medical devices accountable for their deeds. The Ministry may, at most, revoke a license in order to avoid further injury or restrict the manufacturing and sale of specific medical devices under Section 26A.

At the ground level, it is still a difficult problem to figure out how to penalize for the harm that has already been done to patients as a result of carelessness or purposeful misconduct.

After entering into arrangements with third parties, major pharmaceutical corporations frequently have their goods produced by smaller businesses. According to the existing regulations, only the manufacturer may be held accountable if there is any inadequate product quality, and the marketer—typically a well-known corporation and brand leader—will not be subject to any legal action.

And when defective products cause injury, large corporations escape responsibility while tiny businesses bear full responsibility. Additionally, the Act makes no mention of these third-party agreements, which may likewise be prohibited.

CONCLUSION

Recognizing the medications that physicians have prescribed is useful for all citizens, not only doctors and pharmacists. Its knowledge may aid us in refraining from or avoiding carelessness caused by our ignorance of these regulations, as well as defining cautious medico-legal perspectives that relate to medications and poisons. All of us are required to abide by the guidelines set out by laws and legislation.

To assist reduce drug issues, the legal and legislative environment must be supportive: The goal of laws and regulations should be to provide health and social assistance to those who are impacted by substance use, as opposed to sending them to jail or prison. Effective coordination is required between the organizations working to reduce drug demand and harm as well as the sector responsible for controlling the drug supply.

It is necessary to continue gathering and using scientific evidence: Each piece of information would help to gradually enlighten evidence-based policies and programmes to safeguard and advance the welfare of Indian society.

The authors are currently law students.

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Seeking centre’s response on plea for digitisation of medico-legal documents: Madras High Court

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The Madras High Court in the case Dr. Mohamed Khader Meeran A.S v. State of Tamil Nadu observed and has recently sought the response of the Central and the State government on a plea seeking computerisation of medical records having legal importance, including postmortem report, injury report/ accident, etc.
The bench comprising of Chief Justice T Raja and Justice D Krishnakumar heard the case.
It was submitted by the petitioner, Dr Mohammed Khader Meeran that Medico Legal Examination and Postmortem Reporting (MedLeaPR) is a software developed by the National Informatics Centre (NIC) to issue various medico-legal reports and certificates digitally and to store the data in cloud storage in the encrypted form. Presently, the software is being used by many states and union territories in the country.
It was also directed by Madras High Court to implement this software in the state of Tamil Nadu by January 1st 2021. Thus, even though more than an year has passed, no effort has been made by any authority to implement the same, it was averred. The petitioner added that there is no standard proforma that exists in the State.
It was also contended by him that the present proforma is not at all at par with the standards prescribed by the Supreme Court in the case Samira Kohli Vs Dr. Prabha Manchanda And Anr., Civil Appeal No.1949 of 2004.
Further, the petitioner also submitted that documents like Injury Report, Post-Mortem Report (including viscera/chemical analysis report), report of examination after Sexual assault, age estimation reports have legal importance. However, if these are computerised, it would increase the efficiency of hospital administration, governments and the judiciary also.
The petitioner seek directions from the court to implement this software in all the Government hospitals.

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Bail can’t be cancelled without giving notice to accused, giving him an opportunity of being heard: Allahabad High Court

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The Allahabad High Court in the case Rajendra Kumar and 2 Others v. State Of U.P. Thru Prin Secy Home And Another observed that the cancellation of bail cannot be done without giving notice to the accused and giving him an opportunity of being heard.
The bench comprising of Justice Ajai Kumar Srivastava-I observed and has set aside the order of the Sessions Judge, Raebareli cancelling the bail granted earlier to Rajendra Kumar and 2 others in connection with a criminal case.
It was noted by the High Court that the impugned order cancelling the bail was passed without issuing notice to the accused/applicants and without affording them a reasonable and sufficient opportunity of hearing and the same was patently illegal being in flagrant violation of the rulings of the Supreme Court.
With this regard, it was also referred by the court to Apex Court’s rulings in the cases of Samarendra Nath Bhattacharjee vs. State of W.B. and another case of (2004) 11 SCC 165, Mehboob Dawood Shaikh vs. State of Maharashtra (2004) 2 SCC 362, and the case P.K. Shaji alias Thammanam Shaji vs. State of Kerala.
In the present case the accused/applicants were granted bail vide by the Sessions Judge, Raebareli on November 22, 2021. Later, the court was informed that the accused allegedly threatened the witnesses and the complainant to desist from prosecuting the case after being granted bail.
The court finds that the aforesaid conduct of the applicants was violative of the conditions of bail subject to which they were enlarged on bail, it has been directed by the trial court that the applicants be taken into custody and also passed the impugned order cancelling the bail granted to the applicants.
The Applicant challenging the order, moved the Court arguing that in this case and their bail was cancelled without giving them any opportunity of being heard.
The court noted that it is a settled law that once bail has been granted by a competent court after due consideration of the facts and circumstances of the case and the same should not be cancelled in a mechanical manner without there being any supervening circumstance(s) which are not conducive to the fair trial.
However, it was not made clear by the court that trial court would be at liberty to issue notice to the applicants stating therein the grounds which are to be considered by it for cancellation of bail being granted to the applicants.

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Dispute Of Unregistered Partnership Firm Can Be Referred To Arbitration, Bar U/S 69 Partnership Act Not Applicable

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The Calcutta High Court in the case Md. Wasim and Another v. M/S Bengal Refrigeration and Company and Others observed while hearing an application filed under Section 11 of the Arbitration and Conciliation Act, 1996 (‘Arbitration Act’) for appointment of an arbitrator to resolve the dispute between the parties, wherein it was held that the bars for instituting a suit or any other proceeding under Section 69 of the Indian Partnership Act, 1932 (‘Partnership Act’) shall not be applicable to arbitral proceedings under Section 11 of the Arbitration Act.
The present case of the applicants was that, although unregistered, a partnership deed was executed between the applicants and the respondents containing an Arbitration Clause mandating the referral of all disputes and questions to a person who ahs been appointed unanimously to act as an arbitrator.
However, a dispute arose between the parties, subsequent to which, the applicants sent a notice to the respondents invoking the arbitration clause and proposing the name of an advocate as sole arbitrator to resolve the dispute. The respondent denied the appointment of an arbitrator alleging that the allegations raised by the applicants in their initial notice were false. The applicants filed the application under Section 11 of the Arbitration Act for appointment of an arbitrator, aggrieved in these circumstances,
The application was filled by the applicants and it was argued by the respondents that since the partnership firm was ‘unregistered,’ the dispute could not be referred to an arbitrator in view of the application of and the bar created by Section 69 of the Partnership Act, 1932. Further, their case was that since sub-sections (1) and (2) read with sub-section (3) of Section 69 of the Partnership Act restrict the filing of suit by any person as a partner of an unregistered firm including by means of a claim under ‘other proceedings,’ the appointment of an arbitrator could not be seek by the applicant, the partnership deed in their case being ‘unregistered.’
It was observed that Chief Justice Prakash Shrivastava relied on the Supreme Court decision in Umesh Goel v. Himachal Pradesh Cooperative Group Housing Society Limited and on the Madras High Court decision in the case M/s. Jayamurugan Granite Exports v. M/s. SQNY Granites, wherein both of which held that arbitral proceedings shall not come under the expression ‘other proceedings’ of Section 69(3) of the Partnership Act, 1932 and that the ban imposed under Section 69 can have no application to arbitration proceedings and as well of the arbitral award under Section 11 of the Arbitration Act.
Accordingly, it was held by the Calcutta High Court that non-registration of the partnership firm would not attract the bar under Section 69 of the Partnership Act, so far as institution of proceedings as stated under the provision of Section 11 of the Arbitration Act is concerned.

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Supreme Court: Terms Of Invitation To Tender Are Not Open To Judiciary Scrutiny Unless They Are Arbitrary, Discriminatory Or Mala Fide

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Supreme Court

The Supreme Court in the case Airports Authority of India versus Centre for Aviation Policy observed that the terms of invitation to tender are not open to judicial scrutiny, the top court has set aside a Delhi High Court’s order which had quashed the Airport Authority of India’s tender conditions for selecting Ground Handling Agencies (GHA) agencies at Group D Airports.
The bench comprising of Justice MR Shah and the Justice Krishna Murari observed and has stated that the Delhi High Court committed a “serious error” by entertaining a writ petition at the instance of a third party- an group of advocacy called Centre For Aviation Policy -when none of the GHAs challenging the tender conditions. Thus, the writ petition should have been dismissed on the ground of locus standi (Airports Authority of India versus Centre for Aviation Policy).
The court observed that in view of the matter, it is not appreciable how respondent No.1 (CAPSR) – original writ petitioner being an NGO would have any locus standi to maintain the writ petition, wherein challenging the tender conditions in the respective RFPs. Respondent No.1 cannot be said to be an aggrieved party in the case.
The Court stated that the even on merits, the High Court should not have interfered with the tender conditions, observed the Supreme Court. While referring to various precedents regarding limited scope of judicial interference in tender conditions
Further, the court stated that as per the settled position of law, the terms and conditions of the Invitation to Tender are within the domain of the tenderer/tender making authority and are not open to judicial scrutiny, unless they are arbitrary, discriminatory or mala fide and as per the settled position of law, the terms of the Invitation to Tender are not being open to judicial scrutiny and the same being in the realm of the contract. The Government/tender/tenderer making authority must have a free hand in setting the terms of the tender.
The bench observed and has stated that the court cannot interfere with the terms of the tender prescribed by the Government because it feels that some other terms in the tender would have been wiser, fair, or logical.
It was observed that the AAI approached the Supreme Court against the order of the High Court dated July 14, 2021, by which it has allowed the said writ petition of the NGO and has struck down the decision to carry out region-wise sub-categorisation of the 49 airports falling under Group D-1 and the stipulation that only the previous work experience in respect of providing the GHS to scheduled aircrafts shall be considered and will be acceptable. It was also found by the High Court that the revised minimum Annual Turnover criteria of INR 18 crores as discriminatory and arbitrary.
Accordingly, the Supreme Court noted that the AAI explained before the High Court the rationale behind the respective conditions, namely, clustering of 49 airports into 4 region-wise sub-categories/clusters; criteria for evaluation of 36 months having experience in the past 7 years in providing 3 out of 7 Core GHS and the financial capacity and an Annual Turnover of Rs. 30 crores (modified as Rs. 18 crores) in any of the one of last three financial years.
The court stated that while having gone through the respective clauses/conditions which are held to be arbitrary and illegal by the High Court, the court is of the opinion that the same cannot be said to be malafide or/ arbitrary and/or actuated by bias. However, it was for the AAI to decide its own terms and fix the eligibility criteria.

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Court sends Waqf Board scam co-accused to 14 day judicial custody

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A Delhi court on Monday remanded Kausar Imran Siddiqui alias Laddan, co-accused in Delhi Waqf board scam case, to 14 days custody.  

AAP MLA Amanatullah Khan is the primary accused in the case and is out on bail. The Anti-Corruption Bureau (ACB) has stated that Laddan is a fund manager for Khan. The Duty Sessions Judge at Rouse Avenue Court also expressed its displeasure over the non-presence of ACB on the previous date.  

ACB had submitted to the court Ladan’s “handwriting sample” and sought 7 days of custody for him.

The court observed that the agency had not given any reasonable answer for its absence on previous occasion. Thereafter, he was sent to 14 day judicial custody.

AAP MLA was arrested for alleged irregularities in appointment in Delhi Waqf Board during his chairmanship.
Accused Kausar Imran Siddiqui alias Laddan was produced on a production warrant before the court on 27th September. He was interrogated and arrested with the permission of the court.

Laddan’s name came into the frame, when additional public prosecutor Anil Srivastava opposed Khan’s bail plea. He stated that a diary was recovered from Ladan’s house.  It was alleged that he was Khan’s fund manager.  Earlier, the (ACB) had said that money was sent to Dubai and other money transactions need to be investigated. It also stated that a large amount of money was transferred to a party via Dubai. There were 100 people who either received or paid money to Laddan. Out of these 37 people have transactions of crores of rupees.                                                                                                                                                                          

This diary also has an entry about one Zeeshan Haider, who received crores of rupees. He is also a close associate of the accused, ACB had argued. The ACB has also submitted that Laddan is a nominated functionary of a political party. He has photographs with the accused during an iftar party. Additionally, 14 crores sale deed is recovered, which is said to be a ‘Benami property’.

Previously, Ladan was in judicial custody in another case lodged at Jamia Nagar police station. He was arrested from Telangana.

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Solicitor General Tushar Mehta incharge of allocation of cases to ASG’s

Tarun Nangia

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Solicitor General Tushar Mehta incharge of allocation of cases to ASG’s

An office memorandum issued by the Ministry of Law and Justice Indicates that Solicitor General Tushar Mehta would be assigned the responsibility of allocation of cases of ASG’s and panel counsels.
The office memorandum issued September 13th states, A Modification is made in procedure of allocation of cases to Law Officers, Counsel by lncharge Central Agency Section, Branch Secretariats for cases before the Supreme Court and High Courts at Delhi, Mumbai, Kolkata, Chennai & Bengaluru.
In respect of the cases before the Supreme Court, the list of cases on daily basis, will first be placed before the Ld. Attorney General for India for the purpose of his selecting the matters in which he considers his appearance to be necessary. Thereafter, the list of cases will be placed before the Ld. Solicitor General of India who will mark the matters to himself, to the Additional Solicitors General of India to appear alone or with Attorney General for India, Solicitor General of India to the counsel from Group’A’l’B’ l’C’Panel.
Further, in respect of the cases before the High Courts of Delhi, Bombay (PB), Calcutta (PB), Madras (PB) and Karnataka (PB), cases on daily basis will be allocatedand will be marked by the lncharge, Litigation, theBranch Secretariats in consultation with the Additional Solicitor General of India concerned.
It is being directed to ensure strict compliance of the procedure being modified as above to all the subordinate offices of this Department including the Central Agency Section, Litigation (High court) section and all the four Branch Secretariats at Mumbai, Kolkata, Chennai and Bengaluru.
The same being issued with the approval of the competent authority, the office memorandum says.

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