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
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.
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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Disproportionate assets case: Delhi High Court stays Lokpal proceedings initiated against Jharkhand Mukti Morcha chief Shibu Soren
On Monday, the Delhi High Court has stayed the proceedings initiated by Lokpal of India under the provisions of the Lokpal & Lokayuktas Act, 2013 against Jharkhand Mukti Morcha (JMM) Chief and Rajya Sabha MP Shibu Soren in connection with a disproportionate case of assets.
The bench comprising of Justice Yashwant Varma observed and has passed an order on Soren’s plea challenging the validity of the said proceedings, claiming that the same was ex facie bad in law and without jurisdiction.
In the present case, the proceedings were initiated by Lokpal of India pursuant to a complaint dated August 5, 2020 filed by BJP’s Nishikant Dubey. Therefore, it has been directed by the CBI to make a preliminary enquiry into the Complaint under section 20(1)(a) of the Lokpal and Lokayuktas Act, 2013. It was claimed by Soren that the said order was not served on him.
While claiming the complaint was false, frivolous and vexatious, Soren in his plea submitted that according to section 53 of the Act and there is a statutory bar against the Lokpal of India assuming jurisdiction to investigate or inquire into any Complaint made after the expiry of seven years from the offence alleged.
The plea reads that the initiation of the proceedings under the Complaint, or at the very least, continuation thereof, once it has been demonstrated by the preliminary inquiry that it pertains to alleged acquisitions prior to the 7-year period and is clearly barred by statute, without jurisdiction and the same is liable to be quashed.
Further, the petition filled submits that the maximum period of 180 days for completion of preliminary enquiry from the date of Complaint expired on February 1, 2021. In this backdrop, it has been stated that by this time, only on July 1, 2021, the comments were sought from Soren which is beyond the prescribed statutory period.
The plea adds that the final preliminary enquiry report was submitted by the CBI on 29.06.2022, about a year and a half after expiry of the 180- day period. Such purported report is void and null and non-est in the eyes of law and cannot be received or considered by the Respondent No.1.
Thus, the court took note of the order passed by Lokpal of India dated August 4, 2022 directing that proceedings under section 20(3) of the Lokpal Act be initiated to determine whether a prima facie case existed to be proceeded against Soren. It is Soren’s case that the order was passed without considering the preliminary objection on jurisdiction being raised by him.
In the said order, the court noted that all the Lokpal of India recorded was that the comments received from the petitioner were forwarded to CBI so as to examine and submit an enquiry report.
It was ordered by the court that the challenge to assumption of jurisdiction by respondent no. 1 (the Lokpal of India) has neither been answered and nor dealt with. Matters require consideration. Subsequently, there will be a stay of proceedings pending before the Lokayukta.
Accordingly, the court will now hear the matter on 14 December.
DELHI HC SETS ASIDE MURDER CONVICTION & LIFE SENTENCE OF MAN WHO WAS UNPRESENTED BY LAWYER; REMANDS CASTE BACK TO TRIAL COURT
The Delhi High Court in the case Narender @ Lala v. State Of NCT Of Delhi observed and has set aside the orders of conviction for murder and sentence of life imprisonment awarded to a man in 2018 who was unrepresented by a lawyer before the Trial Court. Thus, the Delhi High Court has remanded the case back to the Trial Court for cross examination of certain prosecution witnesses.
The division bench comprising of Justice Mukta Gupta and Justice Anish Dayal observed and was of the view that there had been a grave miscarriage of justice to the man as when number of witnesses were examined, he was not represented by a counsel and that the legal aid counsel, who was present before Trial Court and was appointed on the same day and asked to cross- examine the witnesses on the same day.
On March, 2018, Narender was convicted for offence of murder punishable under section 302 of Indian Penal Code, 1860. On 4th May, 2018, he was sentenced by the Trial Court for life imprisonment and also to pay a fine of Rs. 10,000.
In the present case, the case of the prosecution was that the man had committed murder of his wife by strangulating her to death.
In a appeal, it was argued by the man that during the substantial course of trial, he was not represented by a lawyer and hence the trial in the absence of a lawyer had seriously prejudiced him. He thus sought recalling of all the prosecution witnesses and thereby ensuring a fair trial.
The Court observed that the manner in which the trial is conducted, there was a serious denial of fair trial to the appellant and the appellant is required to be given an opportunity to cross-examine the witnesses i.e., the witnesses examined in the absence of the lawyer, or the lawyer having been appointed on the same day from the legal aid and is asked to cross-examine the witnesses.
Further, the court remanded the back to Trial Court for cross-examination of ten prosecution witnesses. Also, the court directed the Trial Court Judge to follow due process of law and also to record the statement of the man under Section 313 CrPC and permit leading the defence evidence if so required.
The Court ordered that the case be listed before the learned Trial Court on 26th September, when Superintendent Tihar Jail will product the appellant before the learned Trial Court and the learned Trial Court is requested to expedite the trial and conclude the same preferably within four months.
SUPREME COURT REFUSES TO ENTERTAIN PLEA CHALLENGING EXCLUSION OF SC/ST RESERVATION IN JHARKHAND DISTRICT JUDGES APPOINTMENT
The Supreme Court in the case Dr. B.R. Ambedkar Educational And Cultural Trust v. Hon’ble High Court Jharkhand And Ors. observed and has refused to entertain a plea challenging the non-inclusion of reservation for Scheduled Castes, Scheduled Tribes and Other Backward Classes communities in the process of appointment of District Judges in pursuant to an advertisement issued in March, 2022 by the High Court of Jharkhand. The present petition claimed that the exclusion of reservation violates Jharkhand State Reservation Policy and constitutional guarantee under Article 16(4). Apart from this, it is also in derogation of a resolution being passed by the High Court vouching to implement reservation in the Jharkhand Superior Judicial Service.
The bench comprising of Justice D.Y. Chandrachud and the Justice Hima Kohli observed and has granted liberty to the petitioner to file a petition under Article 226 of the Constitution before the Jharkhand High Court.
The court while considering that the process of appointment as per the concerned notification is underway, Justice Chandrachud asked the petitioner to approach the High Court with respect to future appointments.
It stated that “For the future you can file a petition before the High Court… We will give you liberty to approach the High Court under Article 226 of the Constitution.”
The bench of Justice Chandrachud observed that the Decisions of the Administrative side of the High Court can be challenged before the judicial side of the High Court. You can move the High Court.
In the present case, a writ petition challenging a similar notification was filed in 2017 before the High Court, which was eventually dismissed. It was observed by the High Court that there is no duty vested in the authorities to reserve seats for all posts, more particularly in higher judiciary. Moreover, it had already initiated the appointment process, the High Court opined that it cannot alter the rules midway. Thus, the appeal filed before the Apex Court was also dismissed.
However, in 2018 the Full Court of the Jharkhand High Court had agreed in principle to grant reservation in the recruitment for Jharkhand Superior Judicial Service. The advocates belonging to the SC/ST/OBC communities in 2021 had made representations to the Chief Justice of the High Court requesting for the implementation of the Reservation policy in appointment of District Judges (direct entry from Bar)/ superior judicial service. The impugned notification was issued without incorporating reservation for SC/ST/OBC communities in March 2022.
Mr. Arvind Gupta, Advocate on Record has filled the present petition.
Right to contest election is not a fundamental right; it is only a right conferred by statute: Supreme Court
The Supreme Court in the case Vishwanath Pratap Singh vs Election Commission of India observed that the right to contest an election is not a fundamental right but only a right conferred by a statute.
The bench comprising of Justice Hemant Gupta and the Justice Sudhanshu Dhulia observed while dismissing a Special Leave Petition filed by Vishwanath Pratap Singh that an individual cannot claim that he has a right to contest election and the said stipulation violates his fundamental right, so as is required under the Act, to file his nomination without any proposer.
Also, the court imposed a cost of Rupees one lakh on Singh.
In the present case, Singh had first approached the Delhi High Court challenging a notification issued by Election Commission of India for election to Rajya Sabha after he was not allowed to file his nomination without a proper proposer being proposing his name. His contentions were rejected by the High Court that his fundamental right of free speech and expression and right to personal liberty has been infringed.
While dismissing the SLP, the Apex Court observed that the writ petition before the High Court was entirely misconceived.
The bench observed while referring to earlier judgments viz Javed v. State of Haryana, (2003) 8 SCC 369 and Rajbala v. State of Haryana (2016) 2 SCC 445 wherein it was stated that the right to contest an election is neither a fundamental right nor a common law right. It is a right conferred by a statute.
However, the Supreme Court in Javed (supra) had made the following observations: Right to contest an election is neither a fundamental right nor a common law right and it is a right conferred by a statute. At the most, in view of Part IX having been added in the Constitution of India that a right to contest election for an office in Panchayat may be said to be a constitutional right and a right originating in the Constitution and given shape by a statute. But even if, it cannot be equated with a fundamental right. It is stated that there is nothing wrong in the same statute which confers the right to contest an election also to provide for the necessary qualifications without which a person cannot offer his candidature for an elective office and also to provide for disqualifications which would disable a person from contesting for, or from holding, an elective statutory office.
It was held in Rajbala (supra) that the right to contest for a seat in either of the two bodies is subject to certain constitutional restrictions and could be restricted further only by a law which the parliament made.
Further, the court added that Singh did not have any right to contest election to the Rajya Sabha in terms of the law made by the Parliament.
The Court stated while dismissing the SLP that the Representation of People Act, 1950 read with the Conduct of Elections Rules, 1961 has contemplated the name of a candidate to be proposed while filling the nomination form. However, it cannot be claimed by an individual that he has a right to contest election and the said stipulation violates his fundamental right, so as to file his nomination without any proposer as is required under the Act.
Post-conviction compounding of offences is permissible: Himachal Pradesh High Court
The Himachal Pradesh High Court in the case Shri Kantu Ram v Shri Beer Singh recently observed that a court, while exercising powers under Section 147 of the Negotiable Instruments Act and can proceed to compound the offences even after recording of conviction by the courts below.
The bench comprising of Justice Sandeep Sharma observed in a case where the revision Petitioner, who was convicted under Section 138 of the NI Act by the Magistrate Court and was aggrieved by subsequent dismissal of appeal by the Sessions Court and had agreed to pay the amount due and settle the matter.
Thus, the petitioner had sought compounding of offences.
In the present case, the respondent admitted the factum with regard to receipt of the amount due from the accused and expressed that the prayer made on behalf of accused for compounding of offence can be accepted.
However, the High Court allowed the prayer and the offence committed by the Petitioner under Section 138 NI Act was ordered to be compounded.
The Court observed that the Reliance was placed on Damodar S. Prabhu V. Sayed Babalal H. (2010) 5 SCC 663, wherein the Apex Court has categorically held that court, while exercising power under Section 147 of the NI Act and can proceed to compound the offence even after recording of the conviction by the courts below.
‘Pensionary benefits to employee, who is removed from service for misconduct, is not at par with those who retire on superannuation’
The Jammu and Kashmir and Ladakh High Court in the case Bashir Ahmad Wani v Jammu and Kashmir Grameen Bank and Another recently observed and stated that an employee who is removed from service for misconduct is not at par with those who is being retired on superannuation.
The bench comprising of Justice Sanjeev Kumar observed while dismissing the pension claim made by a former employee of the J&K Grameen Bank, who was removed from service in 2011.
In the present case, the petitioner had sought benefit of the J&K Grameen Bank (Employees) Pension Regulations, 2018 whereby provision was made for terminal benefits.
However, the court disallowed the claims on two grounds:
Firstly, that at the time of removal of the petitioner from service when there were no norms, rules or regulations providing for the benefit of pension to the employees of the respondent-Bank.
In the year 2011, the employees of the respondent-Bank were governed by the J&K Grameen Bank ( the Officers and Employees) Service Regulations, 2010… it is abundantly clear that it does not prescribe imposition of a penalty of removal along with the pensionary benefits.
Secondly, it was opined by the court that though the 2018 Regulations had been made applicable to those employees who were in service between 1st day of September, 1987 and 31st day of March, 2010 and the employees retired from the services of the Bank before 31st day of March, 2018, however, this leeway cannot come to aid of the Petitioner.
The Curt observed that the reason for finding that the Petitioner was not an employee who had “retired” on superannuation from the bank. Rather, he was “removed” for misconduct.
The Court stated that the regulations apply to those employees who retired from the service of the Bank before 31.03.2018 and not the employees who were terminated for misconduct. Viewed thus, the order of removal of the petitioner dated 02.09.2011 holding the petitioner entitled to terminable benefits and cannot, by any stretch of reasoning, be construed to be an order of removal with the benefit of the pension. Neither, the petitioner, at the time of his removal from service, nor with the promulgation of Pension Regulations of 2018, is entitled to the benefit of pension.
Accordingly, the court dismissed the petition.
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