Lodge a complaint against the pharma company if its medicine causes a reaction or physical distress

No matter how much we take care of our health, we have to go to a doctor or vaidya due to some illness. They prescribe Allopathic, Ayurvedic or Homeopathic medicines, which we have to buy from the pharmacists as per the prescription.

Sometimes, after taking medicines, we may have an allergic reaction and / or physical distress. In such a situation, we must immediately report it to our doctor or vaidya, and to the District Drugs Inspector. Upon receiving the complaint, the Inspector inspects the respective pharmacy.

Then, a sample of the relevant medicine is sent to ‘Drugs Control Laboratory’, Bandra (Mumbai) for testing. Authorised Analysts test these medicines in a lab. If the medicine sample is found to be uncertified, counterfeit, or adulterated, the Drugs Inspector conducts an inquiry against the pharmaceutical company and pharmacist. A lawsuit is filed against the company.

Sometimes the accused from the original State or other States are arrested on the basis of a complaint filed with the Police. After
the investigation, a case is filed in the Court. Upon conviction, the Court sentences the accused either to imprisonment or imprisonment with a fine.

In this regard, information about the offices of the Drugs Inspector and Drugs Control Laboratory for lodging a complaint in the event of a reaction or physical distress caused by the use of medicines is given here.

1. Laws regarding medicines

The following laws are in force to control the production, sale, distribution, misuse of medicines, use at the personal level by hospitals and doctors, hoarding, cost of medicines, etc.

A. Drugs and Cosmetics Act 1940 & Rules

B. Drug Price Control Order 1995

C. Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules

D. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules 1955

2. In case of adverse effects of a medicine, lodge a complaint with the Assistant Commissioner of Food and Drug Administration in the District

A. Sometimes, after taking medicines, the patient may have an allergic reaction and physical distress. In such a situation, the patient must immediately report the matter to his doctor. In case of a doubt about the quality of Allopathic, Ayurvedic, Homeopathic medicines or cosmetics or in the event of a reaction or physical distress due to the medicines, the customer / patient or their relatives should lodge a written complaint to the Assistant Commissioner at the Food and Drug Administration’s office in the respective District.

B. When lodging the complaint, submit the bottle of syrup or medicine strip along with the receipt for further testing and thorough inquiry. Ensure that you ask for an acknowledgement of the complaint.

C. Initially lodge a complaint with the Assistant Commissioner of the District. If the investigation conducted by the District Assistant Commissioner is unsatisfactory, lodge a complaint with the Divisional Joint Commissioner’s Office.

D. If the inquiry report by the Divisional Joint Commissioner is unsatisfactory, lodge a complaint with the Commissioner, Food and Drug Administration, Bandra (East), Mumbai or with the Ministry of Health and Family Welfare.

E. Follow up the complaint in writing and verbally about the action taken. Also ask for a written report about the final action taken on the complaint.

3. What action is taken after a complaint is lodged ?

If the complaint is found valid, action may be taken against the concerned pharmaceutical company or the pharmacist as given ahead.

A. Pharmaceutical company or the pharmacist are inspected and sent a ‘Show cause’ notice about any deficiencies, and their drug license can be suspended or cancelled.

B. If the collected sample is found to be uncertified or adulterated, a case is filed against the culprit. Their licence to produce medicines is cancelled or suspended.

C. In such cases, the Court sentences them to imprisonment with a fine.

D. If a producer is from another State, offence is registered with the Police in the State where the crime has taken place, and a case is registered against the accused in the Court under the jurisdiction of that Police station. The accused are also arrested.

E. The Drugs Inspector seizes all the unauthorised medicine stock, which is destroyed only after Court approval.

F. Information on the unauthorised medicines is communicated to the Drug Controllers and Hospitals in all States, Central Government. Appropriate action is taken to stop the sale and use of medicines, and the stock is recalled from the market.

G. In each case, necessary steps in public interest and for public health are taken at the Government level.

H. The complainant can obtain information about the action taken on the complaint, from the concerned office of the Drug Controller.

I. We can get information on the action taken over the complaint, by sending frequent reminders, visiting their office in person and following up with them.

J. If the inquiry report on the complaint is unsatisfactory, the complaint can be lodged with the senior officer.

4. Address of the Food and Drug Administration Office and other related offices

4A. Food and Drug Administration (FDA), Maharashtra (This is a Govern-ment office)

Address : Commissioner, Food and Drug Administration, Maharashtra, FDA Building, 341 Bandra-Kurla Complex, Bandra (East), Mumbai; E-mail : [email protected]; Website :fda.maharashtra.gov.in; Tele. : (022) 6592363

4B. Regional Offices : The regional offices of FDA are located in Mumbai, Pune, Nashik, Thane, Amravati, Aurangabad and Nagpur, and in each District, there are offices of Assistant Commissioner and Drugs Inspector, and FDA Maharashtra State’s officers

5. Precautions consumers can take regarding medicines

A. Do not self-medicate. Always take medicines prescribed by doctors / vaidyas.

B. Schedule medicines can cause bodily harm if consumed without the advice of doctors. Therefore, these medicines should not be taken without the advice or prescription of the doctors. Dosage and time of taking the medicine should also be as prescribed by the doctors.

C. Buy medicines only from registered pharmacists. These medicines should be bought on the prescription of doctors and a receipt must be taken for the payment made. You should insist that the pharmacist gives a receipt. According to law, pharmacists are obliged to give a receipt for every Allopathy medicine sold. Selling a medicine without receipt is a crime. You should buy medicines only against receipts for your own good. Receipts should be preserved as long as the medicine is in use.

D. Ensure that medicines are as per the prescription of the doctor. If in doubt, get the medicine checked by the doctor before taking it.

E. When buying medicines, check their ‘Expiry date’. Do not buy medicines that have passed their expiry date.

F. Labels and instructions on medicines should be verified. If the medicine is to be stored in a refrigerator, it should be stored accordingly at home, and other instructions on the label should be carefully read. The medicine should be kept away from the sun or stove, heat, etc. The medicine’s label has instructions regarding the temperature at which it should be stored; follow these instructions.

G. Any old left-over or partly-used medicines should not be used again; rather they should be destroyed. Due to unforeseen circumstances, if it becomes necessary to reuse such medicines, use only after verifying the expiry date.

H. Read the medication guide supplied along with the medicine in detail, as well as information printed on the package such as storage, expiry date, cost, etc.

I. Verify the retail price printed on the medicine package and the price charged in the receipt. If the pharmacist charges more than the MRP, question him and ask for a refund of the overcharged amount. Lodge a complaint with the District office of FDA along with a copy of the receipt if the pharmacist refuses to give receipt for the overcharged amount. Selling medicines at a higher price is an offence under the Drug Price Control Order (DPCO), 2013. Offenders can be punished with imprisonment up to 7 years.

J. All medications in the house should be kept away from children. These should neither be kept exposed to the atmosphere nor discarded outside. Take extreme care so that children do not get hold of the medicines in the absence of parents. Medicines should preferably be kept under lock and key.

K. In the event of adverse physical reactions or harm caused by the medicine, stop using it immediately.

This information should be immediately provided to the doctor and further treatment should be taken with his advice. The complaint should be made to the nearest FDA office against the concerned pharmacist along with the relevant medicine details and vendor’s batch number. The complaint along with left-over medicines and the purchase receipt should be submitted to the Drugs Inspector for further tests and thorough inquiry, acknowledgement of the receipt of these documents should be obtained.

L. Medications that induce sleep, nar-cotic drugs & Psychotropic substances, etc. such as Gardenal Tablet, Diazepam Tablet, etc. are addictive. Such drugs should be administered under the supervision of expert doctors. – Advocate Hindurao Salunkhe, Bombay High Court, Mumbai.