The pharmaceutical industry in Himachal Pradesh is rolling out drugs in market without there being a system in place to ensure that drugs conform to required standards, thus playing with lives of people at large. And all this is being done under the nose of Drug Control Organisation.
The CDSCO- Central Drugs Standard Control Organisation -conducts drugs tests at random and so far Himachal Pradesh is concerned, it found 181 substandard drugs from April 2022 to March 2023. As per required procedure, each manufacturer is required to have a separate quality control lab in its establishment, which majority of manufacturers do not have. Further, before a drug is launched in market, the approved labs are required to certify that drugs conform to required standards. Since all these drugs were found to be substandard after they were sent to markets, it means that certificates of fitness given by approved labs are false. The complicity of statutory authorities cannot also be ruled out. The State has failed to protect the life of its citizens by not controlling the circulation of fake drugs.
Since Right to Life of citizens at large was violated not only by manufacturers of drugs but also by State, PeRGo decided to file a Public Interest Litigation in High Court of Himachal Pradesh seeking to ensure that quality drugs are available in market and these are circulated only after having been checked thoroughly with respect to standards and quality.
In terms of volume, India’s pharmaceutical industry ranks third in the world. The state of Himachal Pradesh has the biggest drug manufacturing industry in the whole of Asia. The drugs manufactured in Himachal are consumed throughout the country and in foreign countries. But the problem with it is that there is no robust infrastructure available to check the quality and credibility of these drugs.
Many complaints have arisen all over India and even from foreign countries, claiming that the drugs manufactured in Himachal industrial belt are spurious and have gulped the lives of many innocent consumers. This problem has arisen due to many factors, including the lack of adequately equipped laboratories. Baddi, which is one of the biggest hubs of medicine does not even have a proper up-to-the-mark laboratory. For most of the tests, the manufacturers have to send their drugs to the laboratory in Chandigarh. Many times, these manufacturers skip the proper testing of drugs and send their products straight away to the market, which causes havoc in the market and takes away the lives of many innocent consumers. The omission of the State to provide a fully up-to-date and equipped laboratory for testing of drugs has resulted in utter violation of Article 21 – Right to Life.
Though, a drug-testing lab being set up by the industries at Baddi is still dysfunctional since its inception in 2014. The civil work was completed at a cost of Rs 3.25 crore, years ago, but it failed to become functional. In the year 2017, the Union Ministry of Health and Family Welfare provided Rs 30 crore to the state Health Department to set up a new lab as part of the 12th Five-Year Plan. But it is yet to become functional. This shows a grave failure on the part of the government.
Drug testing laboratory at Baddi, which is yet to be made functional, is proving a burden on the state exchequer with the government coughing up a monthly electricity bill of nearly Rs 1 lakh, besides paying salary to two deputy analysts sitting idle for over a year now. Due to the consumption of spurious and substandard drugs manufactured in India, many citizens of foreign countries have lost their lives. It affects trade and international relationships as well as portrays a bad image of the country on an international level.
As per the figures provided by the drug authorities in the Vidhan Sabha to a question raised by the former Health Minister, 74 drugs were declared substandard in Himachal Pradesh. Interestingly, as per the national level alert issued every month by the central drugs regulator, Central Drugs Standard Control Organisation, as many as 181 drug samples were declared substandard in 2022 alone. The state has 660 pharmaceutical units housed in various industrial clusters like Baddi-Barotiwala-Nalagarh, Kala Amb, Paonta Sahib, Parwanoo etc., still the state lacks well-equipped drug testing labs and it is dependent on the Chandigarh-based Regional Drugs Testing Laboratory as well as its ill-equipped Kandaghat-based Composite Testing Laboratory to test drug samples.
The provisions of the Drugs and Cosmetics Act and Drugs and Cosmetics Rules require that the manufacturers/licensees are required to manufacture drugs according to prescribed standards that are not substandard, spurious, or adulterated. However, the data placed on record shows that sub-standard or spurious drugs found every other day, which have been manufactured by licensed manufacturers. It also shows that the mechanism provided under the Act and Rules has either not been implemented or failed to achieve the required results. The State has failed to implement the provisions of the Act.
Usage of drugs and the Right to Life Under Article 21 of the Constitution of India are closely interlinked. It is the Constitutional right of every individual and this right is defeated when he is made to purchase medicines which are spurious, substandard or adulterated. The failure of the state to supervise the production of drugs and maintain required standards has led to the violation of Article 21 of the Constitution of India of people at large.
Drugs and Cosmetics Rules, inter alia, provide for a separate and independent quality control check by every manufacturing unit. This quality control department is to be manned by quality staff and is required to maintain the specific standard. The reports after this quality control check are required to be submitted for approval of the authorities and it is only thereafter that the drug can be passed for sale in the market. It is apparent from the material placed on the record that most of the manufacturers do not have in house quality control department within the establishment. It is surprising that without having such quality control checks, the manufactured drugs are permitted to be sold in the market. Not only the manufacturers but also the respondent authorities have also failed to implement the provisions of the Act and Rules.
It is prayed before the Hon’ble High Court of Himachal Pradesh only those drugs may be permitted to be sold in the market which has been approved by in-house Quality Control Check as well as by the independent lab. The respondents may be directed to initiate the proceedings for cancellation of the Licences of those manufacturers, whose drugs were found not conforming to required standards under Drugs and Cosmetics Act and may be directed to follow the provisions of Drugs and Cosmetics Act and Rules meticulously before the drugs are sent out in the market for sale.
After the petition was filed by PeRGO, the honourable High Court of Himachal Pradesh issued a notice on 24.05.2023 and directed the respondents to disseminate information with regard to the utilization of a sum of Rs. 30 crores which had been sanctioned by the Central Bank for setting up a lab way back in the year 2017. The court also insists to inform about the status with regard to another testing lab that was being set up by the Industries at Baddi in the year 2014 and the status of the civil work which was alleged to have been completed at the cost of Rs. 3.25 crores, that too, five years back and the State shall also inform the Court as to how many posts of Drug Inspectors are lying vacant and what steps are being taken to fill up the same.