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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SC Collegium Recommends elevation of Justice Prasanna B. Varale as Karnataka HC Chief Justice; Recommends New CJs For Orissa, J&K
The Supreme Court Collegium has recommended elevation of Justice Prasanna B. Varale, Bombay High Court Judge as the Chief Justice of Karnataka High Court.
Justice Prasanna B. Varale was born on 23rd June, 1962 and enrolled as an Advocate on 12th August, 1985. He also served as a lecturer in Law at Ambedkar Law College, Aurangabad from 1990 to 1992 and as the Assistant Government Pleader and Additional Public Prosecutor, High Court Bench at Aurangabad and also as an Additional Standing Counsel for Union of India.
On July, 18., he was elevated to the bench at Bombay High Court.
The Supreme Court Collegium also recommended to elevate of Orissa High Court Judge, Justice Jaswant Singh, as its Chief Justice.
Justice Singh was February 23, 1961 and was enrolled as an Advocate in 1986 in Haryana. In April 1988, he moved to Chandigarh and held the posts of Assistant Advocate General, Deputy Advocate General, Senior Deputy Advocate General and Additional Advocate General, in the office of Advocate General, Haryana, since March 1991.
On December 5, 2007., he was elevated as a Judge of Punjab and Haryana High Court and on 8th October, 2021., he was transferred to the Orissa High Court.
The Collegium also J&K High Court’s Judge, Justice Ali Mohammad Magrey to take charge as the Chief Justice.
Justice Magrey was born on 8th December, 1960 and enrolled as Advocate in the year 1984. However, he remained as standing counsel from 1986 onwards for various State instrumentalities and was appointed as Additional Advocate General in February, 2003. In September 2009, he was appointed as Senior Additional Advocate General.
On 8th March, 2013., he was appointed as Permanent Judge of the Jammu and Kashmir High Court.
Supreme Court Collegium Recommends Transfer Of 3 Judges To Bombay, Jharkhand & Tripura High Courts
The Supreme Court Collegium has recommended transfer of three Judges in its meeting held on 28th September, 2022 in the following manner:
The transfer of Justice Sanjaya Kumar Mishra from Uttarakhand High Court to Jharkhand High Court
Justice Mishra was born on December 29, 1961 and has obtained his LL.B. degree in 1987 and in February 1999 joined as Additional District & Sessions Judge. However, he worked as District & Sessions Judge, Sundergarh, Dhenkanal, Special Judge (CBI), Bhubaneswar and has joined as Registrar General of Orissa High Court.
On October 7, 2009., he was elevated as Judge of the Orissa High Court and was transferred to the Uttarakhand High Court on October 11, 2021. Between December 24, 2021 and June 28, 2022, he served as the Acting Chief Justice of Uttarakhand High Court.
The transfer of Justice K. Vinod Chandran from the Kerala High Court to Bombay High Court
Justice K. Vinod Chandran was born on April 25, 1963 and has started his law practice in 1991. Also, he served as a Special Government Pleader (Taxes) of the Government of Kerala from 2007 to 2011. In November 2011, he was sworn-in as Additional Judge of Kerala High Court and was appointed as a Permanent Judge with effect from June 24, 2013.
The transfer of Justice Aparesh Kumar Singh from Jharkhand High Court to Tripura High Court
Justice Singh was born on 7th July, 1965 and got enrolled as an advocate at Patna in 1990. On 24th January, 2012., he was elevated as an Additional Judge of Jharkhand High Court and was confirmed as permanent Judge on 16th January, 2014. Presently, he is holding an additional charge as Executive Chairman of Jharkhand State Legal Services Authority.
Kerala High Court Directs Union Health Ministry And Department of Pharmaceuticals To File Response: Patents On Life Saving Drugs
The Kerala High Court while taking serious note in the case XXX v. Union of India of the unaffordability of a life-saving patented medicine for breast cancer, the Court directed a competent officer of the union health ministry and the department of pharmaceuticals for filing their response on the issue within a month.
A direction has been issued by the Court after noting that the matter had to be taken up at the higher level.
The bench of Justice V.G. Arun observed and has warned that if the counter is not filed within the stipulated time, the court would be constrained to proceed with the case based on the “uncontroverted averments in the writ”.
During the hearing, the counsel appearing on behalf of the Department for Promotion of Industry and Internal Trade (DPIIT) and the Controller General of Patents, Patent Department, Standing Counsel T.C. Krishna submitted that the situation to invoke Sections 92 and 100 for compulsory license of the patented drug as sought for in the petition and was not prevalent as of present.
Further, it was asked by the counsel that how far the court could interfere in this case, since the plea had sought that the drug be made available at a reasonable price. Adding to it, he questioned that weather the Court could suggest what a ‘reasonable price’ would be to the government.
In response to the question, it was clarified by advocate Rahul Bajaj that cancer was not part of the list of the notifiable diseases list issued by the Central Government.
The Amicus Curiae, Advocate Maitreyi Sachidananda Hegde submitted that the authority to take decision under Section 92 or Section 100 of the Patent Act ought to be of the Joint Secretary level as the Assistant Patent Officer could not decide whether the issue falls within the government realm or not.
It was also argued by the Amicus that the legal question which has been raised could be decided by the Court.
Further, it was submitted by Amicus that the counter Affidavit that had been submitted by DPIIT and Patent Department suffered from certain drawbacks for not addressing whether reasonable discretion had indeed been exercised in the instant case or not.
The Counsel appearing for the respondent refused while stating that the government has to take the decision in this regard, before the Patent Department could go ahead with compulsory licensing or any other such measure.
Representing an intervenor, Advocate Bajaj pointed out that the right to health in Indian and International spectrum includes within its ambit the right to life-saving medicines, as well. Hence, it was submitted by the counsel that the issue could not merely be looked into from a policy lens alone, but that it is a rights-based issue in itself.
The Court on 16.09.2022., had taken a suo motto cognizance of the issue of unaffordability of patented life-saving medicines, in light of the death of the petitioner who had espoused this cause having not been able to afford the Ribociclib drug for the treatment of her breast cancer.
Accordingly, the court posted the case for the next hearing on 2nd November 2022.
Allahabad high court: Not mandatory to summon lower court record before deciding state’s plea for grant of leave u/s 378(3) crpc
The Allahabad High Court in the case State of U.P. v. Vakil S/O Babu Khan observed and has held that it is not mandatory for the High Court to summon the lower court record in every case before deciding the State Government’s application for grant of leave to appeal against an acquittal order as provided under Section 378(3) Cr.P.C.
It stated that section 378 Cr.P.C. provides for filing of appeal in case of acquittal by the State and sub-section 3 of Section 378 Cr.P.C. contemplates for grant of leave for the entertainment of such appeals filled.
The bench comprising of Justice Ashwani Kumar Mishra and Justice Shiv Shanker Prasad observed and has stated that it is for the High Court to decide on the basis of the facts and circumstances of each case that whether the application filled for grant of leave requires the perusal of the lower court records or not.
However, the court was of the view that though the right of the appellate court to summon the lower court record in an appropriate matter always subsists and it is not necessary for the High Court to call for the lower court records for consideration of an application under Section 378(3) Cr.P.C., in every case or as a matter of routine.
The Court also referred to the Apex Court’s ruling in the case of State of Maharastra Vs. Sujay Mangesh Poyarekar (2008) 9 SCC 475, wherein it was observed that the High Court while exercising the power to grant or refuse leave must apply its mind and considering where a prima facie case has been made out or arguable points have been raised and not whether the order of an acquittal would or would not be set aside.
It was observed that the court also took into account sub-section 2 of Section 384 Cr.P.C. which provides that before dismissing an appeal, summarily, the Court may call up for the record of the case. Thus, the court noted that non-summoning of the lower court records in an appeal against conviction is not fatal and that the use of the expression ‘may’ in sub-section (2) clearly suggests that the power to summon the record is only an enabling provision and as shall it is not to be read.
Further, the court stressed that every appeal is not required to be admitted inasmuch as leave must not necessarily be granted in every matter and the exercise of power in that regard is dependent before the Court upon a prima facie assessment of the material placed so as to ascertain whether the appeal raises arguable points or not.
Subsequently, the Court came to the conclusion that it is not mandatory for the High Court to summon the lower court record in every case before deciding the application for grant of leave under Section 378(3) Cr.P.C.
It was added by the court that the right of the appellate court to summon the lower court record in an appropriate matter always subsists and It is for the High Court to decide on the basis of the facts and circumstances of each case that whether the application for grant of leave requires the perusal of the lower court records or not.
All women, married or unmarried, entitled to safe and legal abortion: SC
In a landmark judgement this week, the Supreme Court held that all women are entitled to a safe and legal abortion. A bench headed by Justice D.Y. Chandrachud said that the meaning of rape must include marital rape for the Medical Termination of Pregnancy Act.
The Supreme Court said that the distinction between married and unmarried women for the purposes of the MTP Act is “artificial and constitutionally unsustainable” and perpetuates the stereotype that only married women indulge in sexual activities.
The rights of reproductive autonomy give similar rights to unmarried women as those to married women, the bench held.
Insisting on a “forward-looking” approach, the Supreme Court on 7 August opined that any discrimination between married and unmarried women in respect of the medical termination of pregnancy law in India that does not allow a single woman to go for an abortion after 20 weeks violates her personal autonomy.
The top court had said that it would interpret the Medical Termination of Pregnancy (MTP) Act and the related rules to see if unmarried women could be allowed to abort up to a 24-week pregnancy on medical advice.
The upper limit for the termination of pregnancy is 24 weeks for married women, with special categories including survivors of rape and other vulnerable women such as the differently-abled and minors; the corresponding window for unmarried women in consensual relationships is 20 weeks.
SEBI v/s RIL : Review Petition Admitted
The present issue relates back to certain share transactions of RIL in 1994, whereby around 12 crore equity shares of RIL were “fraudulently” allotted to its promoters and group companies.
The Supreme Court in the case Securities and Exchange Board Of India vs. Reliance Industries Limited & Ors observed and has allowed for listing of the instant petition in open court.
The bench comprising of the Chief Justice Of India U.U. Lalit, Justice J.K. Maheshwari and the Justice HimaKohli observed while considering the facts and circumstances of the case and on the submissions made by the counsel in the review petition. The bench deemed it appropriate to allowe the application filled for the listing of the instant petition in open court.
Background of the Case:
The present issue relates back to certain share transactions of RIL in 1994, whereby around 12 crore equity shares of RIL were “fraudulently” allotted to its promoters and group companies. In 2020, a complaint was filled by S Gurmurthy, the regulatory initiated probe into the alleged irregularities. An opinion was sought by SEBI of former Supreme Court judge Justice BN Srikrishna twice and also the opinion of a Chartered Accountant named YH Malegam.
It was requested by the RBI for disclosure of these opinions and related internal documents. The RIL filed a writ petition before the Bombay High Court, when SEBI turned the request and the same was dismissed in February 2019.
A Criminal complaint was lodged by SEBI in 2020 before Special Judge, Mumbai against RIL alleging offences punishable under SEBI Act and Regulations. The same was rejected by the Court as time-barred. A revision petition was filled by the regulatory before the Bombay High Court challenging the dismissal of the complaint. However, in SEBI’s revision petition, RIL filed an interlocutory application seeking the disclosure of the documents. The High Court adjourned RIL’s application on March 28, 2022 by stating that it can be considered only along with the main revision petition. Therefore, this led to filling of the special leave petition before the Supreme Court.
On September 29, 2022., the matter was circulated in the Supreme Court. Accordingly, the court listed the review petition for next hearing on 12.10.2022.
Case Title: Securities and Exchange Board Of India vs. Reliance Industries Limited & Ors
Case No: W.P.(C) No. 250 of 2022 & W.P.(C) of 1167 of 2022.
Coram: Chief Justice Of India U.U. Lalit, Justice J.K. Maheshwari, Justice Hima Kohli
Date Of Order: 29th Day of September, 2022.
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