Srinagar, July 27: The High Court (HC) of Jammu & Kashmir and Ladakh Wednesday directed the central government to file reply in a Public Interest Litigation (PIL) seeking ban on the sale and distribution of drugs manufactured and distributed by unregistered companies in J&K.


The court granted a month’s time to Assistant Solicitor General of India (ASGI), T.M Shamsi to submit a reply in the matter.


The government counsel representing the J&K government submitted that its reply is ready and they will furnish it by tomorrow in view of the seriousness of the matter.


The court was hearing a PIL filed by lawyer Naveed Riaz through counsel Mohammad Altaf Khan highlighting the sale and distribution of misbranded, substandard and spurious drugs in Union Territory (UT) of J&K.


The petitioner has submitted that the unregistered companies are manufacturing the drugs and the distributors who are not legally entitled to distribute medicines are distributing fake, spurious and misbranded drugs in every nook and corner of J&K. “Besides there is no system to control the menace of self-medication in the UT.”


“J&K is a victim of fake and spurious drugs which has made it heaven for the unregistered and notorious drug manufacturers,” he submitted.


He contended that there is no system or mechanism for fixing responsibility for manufacturing and distributing fake drugs in J&K which is in direct violation of Drugs and Cosmetics Act 1940 and and the Rules thereunder.


He further submitted that the government authorities have also failed to conduct regular sampling and testing of these medicines which they are bound to do by law.


Meanwhile, the reply filed by the respondents, Drug Controller & Deputy Drug Controller, Drugs and Food Control Organisation (DFCO), Additional Chief Secretary, Health & Medical Education (H&ME) Department, and Managing Director J&K, Medical Supplies Corporation Limited stated that they have carried out an extensive market check and found that the drugs in circulation are manufactured by companies who have established credentials.


“However, as an abundant precaution, notices have been served to all the companies about whom the petitioner has casted doubts,” they said.


Rejecting the allegations of the petitioner regarding the sale, manufacture and distribution of spurious drugs, the respondents informed the court that the department is convinced that there is no fake entity engaged in Pharma business as per market survey.


Checks and counter checks are in process to obtain complete data from various companies whose names have been listed in the complaint filed by the petitioner, they have said in their response.


The report stated that it needs to be clarified that manufacturing of drugs is an articulate activity which is governed by many regulations in addition to the Drugs & Cosmetics Act,1940.


As per the report, the extent of Not of Standard Quality (NSQ) drugs reported by the government analysts during last 5 years till date accounts to 2.40 % ( Adulterated 0.01 % ; Spurious 0.10 % ; Misbranded 0.89 % ; Failing in other Parameters 1.39 % ; Total = 2.40 % ) which is on the lower side than the National Index.


It stated that the matters of NSQ drugs are dealt with strictly as per directions issued by the government of India under Section 33 (P) of Drugs and Cosmetics Act, 1940.


It was submitted in the report that the aforesaid facts clearly indicate that the petitioner is “ill-advised and ill -informed” about the subject and “therefore his present PIL can shake the public perception & may create apprehensions in the minds of sick and infirm who rely heavily on daily medication to supplement their healthy state.”


Regarding the contention of existence of unregistered companies, the respondents contended that the petitioner has presumably not gone through the label claims of medicinal preparations which are governed by Rule 96 & 97 of the Drugs Rules, 1945.


It underscored that the label has to essentially carry some information such as every drug manufactured in India shall bear on its label the number of the license under which the drug is manufactured, the figure representing the manufacturing license number being preceded by the words “Manufacturing License Number or Mfg. Lic.No. or M.L.” 


It says that the label has to carry the name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured and a distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken.


“Marketer means a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer under an agreement for marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution,” report submitted while mentioning the guidelines.


It underscored that the petitioner has no valid locus standi to agitate a sensitive issue in a court of law without any reasonable logic.


“The petitioner has no instance to quote that the authorities have adopted an immune approach towards their lawful duties. The department is visible to the end- users through the website, complaint redressal mechanism and all complaints received are attended to the entire satisfaction of end-users,” the reply stated.


It was submitted that J&K is a consuming state and has to rely on the supplies from manufacturers located outside its borders for achieving sustainability in patient care.


“There is no record to suggest any loss suffered by the citizens of J&K on account of consumption of any Pharmaceutical preparation,” it says and added, “The UT of J&K has to broadly rely on manufactures in house testing and also the regulatory mechanism available with respective States from where manufactured drugs are entering our UT.”


It contended that at the time when the reply to the petitioner was provided only 39 out of 90 firms mentioned in the complaint had provided the requisite information & process in respect of leftover companies was in active mode.


The report says that the jugglery of words committed by the petitioner is an attempt to mislead the court.


It submitted that Drugs & Cosmetics Act, 1940 and Rules thereunder is a comprehensive regulation and the empowered authorities performing statutory duties under the said Act are competent officers who have acquired experience and technical knowledge.


“The interests of the general public are safe in their hands and as such there is no reason to cast doubts on their ability and competence,” it said.


It was stated that the response to any complaint is a lawful duty of a public servant and any communication which is made on the basis of part findings cannot be construed to be conclusive.


It further stated that the official respondent has responded to the complaint on the basis of available records and therefore there is no reason to castigate the same.


The respondents informed the court that the sampling work executed at the behest of complaint, 119 reports have been received so far and out of it 08 samples have been declared not of standard quality.


“Repetitive narrative of presence of fake and spurious medicines in the PIL appears to be engineered as also doctored. A place where literacy rate stands at 76.75% is not expected to consume unlabelled medicines,” they said.


The court was informed that J&K has obtained a distinction to engage research scholars in analytical work and also achieved NABL accreditation for two Drug Testing Laboratories located at Jammu & Srinagar.


The respondents submitted that the Drug & Cosmetic Act, 1940 and Rules thereunder are amply understandable.


“No drug which requires to be sold by Pharmacy except under a valid prescription can be dispensed by a Pharmacist. However, the fact cannot be denied that a large section of the population resorts to self medication to save consultation fees and consumes medicines on the advice of a Pharmacist,” the report says.


It says that the department is taking administrative measures to check the medication. The retail Pharmacies found violating the condition of license are penalized by way of suspension of their retail licenses.


Meanwhile, the respondents while terming the instant PIL as personal interest litigation, accused petitioner of misusing the forum by filing the current PIL.


“The petitioner purportedly being a practicing lawyer was expected to not venture into this kind of PIL which, ex-facie appears to be motivated and filed at the behest of some contemporary pharmaceutical company manufacturers and dealers etc with a view to settle their business rivalry,” they alleged


The respondents have also filed a complaint for registering an FIR against the petitioner to the Office of Superintendent Cyber Police Wing.


It is also stated in the reply that some parties have filed defamation suits in both wings of the High Court, Jammu & Srinagar and in Delhi as well against the petitioner for harming and bringing disrepute to the Pharma Trade.



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