Are Generic Drugs Cheaper Or More Harmful? - Dr Rajeev Joshi

There is a huge debate regarding doctors not prescribing generic drugs and fleecing patients in collusion with pharmaceutical companies. Doctors on the other hand feel it necessary to protect the right to life of the patients by preventing the sale of spurious drugs. The quality of drugs is more important than cost when it comes to treatment, and the outcome of the treatment depends entirely on the quality.

This debate is not new and not only in India. In 2006, in a study entitled “Patient's attitudes towards and experiences of generic drug substitution in Norway” about 1/3 of the patients who had their medication substituted reported negative experiences. Altogether 50 (36%) of the patients who had experienced a switch, reported one or more negative experiences connected to the substitution, and 29 of these (21%) reported an overall negative experience after the change.

In 2010 Ravinder Sood of the Tribune reported “Generic drug companies fleecing patients”. In the article he wrote, “The Tribune had in its possession the wholesale and retail price list of one dozen major pharma companies reflecting the prices of 1,000 brands of generic medicines that are being used by every third Indian daily. Surprisingly, not only private chemists but also the medical stores owned by the HP State Civil Supply Corporation (An HP government undertaking) have also been selling them in their medical stores and earning high-profit margins ranging from 500 per cent to 1,000 per cent with no check at the government level (As per price list given). It is worthwhile to mention here that in most of the medical stores of the corporation, hoardings reflect "Cheap and Genuine Drugs Available Here".

In reality, it was a cruel joke to the consumers. The fact is that the corporation was allowing a discount of 5 per cent after earning huge margin profits of over 700 per cent. Enquiries made by The Tribune further revealed that HP State Civil Supply Corporation had over 40 retail medical stores situated in key locations inside the hospitals and medical colleges in the state. Patients always prefer to buy medicines from these shops with the impression that they would get standard drugs at reasonable rates in these stores, but contrary to it the HP Civil Supply Corporation was virtually cheating the patients by charging high profits.

In 2013, Generic Drug Manufacturer Ranbaxy Pleaded Guilty and agreed to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA. This indicates that not all generic drugs are without any problems and are safe.

In 2013, the Journal of Pharmacology and Pharmacotherapeutics published a paper on “Safety and efficacy of generic drugs concerning brand formulation”. The paper has stated “ However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations.

In conclusion, the use of generic drugs could be related to an increased number of days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side effects.

In 2014, 15 women died following poor-quality drugs in 2014 in a Govt.- driven Sterilisation programme. The leader of the investigation, police inspector S.N. Shukla, said that preliminary investigations suggested that the deaths were caused by either contaminated equipment or adulterated medicines. According to district medical officer M.A. Jeemani, results of autopsies performed on some of the women who died suggested that the administration of tainted medicines might have caused the women's deaths.

On November 15, two senior Chhattisgarh officials stated that tablets of ciprocin that had been linked to the deaths contained zinc phosphide, a chemical often used in rat poison. This conclusion arose from a preliminary report, and samples of the tablets have been sent to other laboratories for verification. The company responded to this finding by releasing a statement which said that information about the incident had been exaggerated, denying that the pills they produced were contaminated.

After being condemned by Chief Minister Raman Singh on 12 November, Dr Gupta was arrested and subsequently suspended. He said, "It was not my fault - the administration pressured me to meet targets. The surgeries went well but the problem was with the medicines given to the women. On November 14, 2014, the Director of Mahawar Pharma, the company that supplied medicines used in the sterilizations, was arrested and charged with fraud, and the company's drugs were banned from consumption Chief Minister Raman Singh blamed negligence for the incident, and as a result, four health officials were suspended by the state, including the district's chief medical officer. Chhattisgarh Health Minister Amar Agarwal said that the government has banned six unnamed medicines for such operations pending the investigation.

In 2017, it was reported that a patient suffering from Dengue died in a hospital in Delhi and a bill of Rs. 17 Lacs was handed over to the relatives. On investigation of similar cases, the National Pharmaceutical Pricing Authority found that the bills contained Scheduled drugs which are under price control (4.1%), Non Scheduled drugs (which are not under price control (25.67%) and Consumables (9.56%), whereas the charges for consultation, surgery and medical supervision was only 13%. The profit margins on the non-scheduled drugs ranged from 100% to 1500% and that of consumables up to 2000%.

In 2018, Gaurav Saigal of Hindustan Times reported a Fake drug trade racket. The shocking disclosure followed the seizure of fake medicines worth about ₹6 crore after raids on several locations in Uttar Pradesh and Uttarakhand recently, officials said. In UP, the medicine trade has an annual turnover of ₹17,000 crore and officials say 1.5% of this could be from fake drugs.

Starch paste, talcum powder, and calcium phosphate were used to make tablets in different shapes and sizes. “Starch paste, talcum powder, and calcium phosphate are known to cause health problems. Calcium can cause stone formation in the kidneys and gallbladder. Sulphate ion causes gastric irritation in the stomach,” said prof Sanjay Khatri, of the Department of Pharmacology at the King George’s Medical University, Lucknow. The ₹6 crore fake drug haul could just be the tip of the iceberg, officials said.

In 2022, the FDA alerted healthcare professionals of risks to patients exposed to xylazine in illicit drugs. According to the CDC, 107,735 Americans died between August 2021 and August 2022 from drug poisonings, with 66 per cent of those deaths involving synthetic opioids like fentanyl. The Sinaloa Cartel and Jalisco Cartel in Mexico, using chemicals largely sourced from China, are primarily responsible for the vast majority of the fentanyl that is being trafficked in communities across the United States.

Healthcare professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects. FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin, and other illicit drugs contaminated with xylazine, the report said.

In 2023, Reuters found in its investigation that one of the Indian pharma companies, Marion Biotech, used industrial-grade ingredients, used in making detergents, and paints, for producing cough syrup. Since last October, there have been four different incidents where India-made cough syrups and eye drops have been linked to deaths.

Besides the deaths in Uzbekistan, at least 70 children died in Gambia last year after taking cough syrups made by another company in India that were found to be contaminated with the toxins, and tainted cough syrups made in Indonesia were linked to the deaths of more than 200 children there. This was reported by the MINT.

In June 2023, PGIMER doctors refused to use the free drugs given to them for their illness by an in-house pharmacy. Most of the PGI faculty members — both former and present — do not take medicines from the staff dispensary.

According to a recent study conducted by researchers from PGI, Chandigarh, some generic medicines are ineffective in certain chronic diseases. The study published in Mycoses revealed that the likelihood of patients responding to generic drugs is significantly lower in some cases. The study's findings showed that 73% of the patients reported improvement after two weeks. In contrast, only 29% of patients given generic drugs responded to the treatment.

In August 2023, Fake medicines worth ₹2 crore were seized in Kolkata, and arrests were made following raids by the Health Ministry. The CDSCO East Zone, Kolkata, unearthed counterfeit medicines of about ₹2 crore across manufacturers like Sun Pharmaceutical, Alkem, Cipla, Glenmark, GSK, Abbott, Novartis, Dr Reddy’s, and Aristo among others.

In 2023, On 1oth August, the Indian government suspended manufacturing in over 40 pharma companies based on a risk-based assessment conducted earlier in the year across 162 firms, according to the data provided by Union Health Minister Mansukh Mandaviya in Parliament on Thursday. “Overall, a sum of 143 show-cause notices has been issued,” Mandaviya said.

There have been numerous recent incidents involving accusations from foreign countries regarding the contamination of syrups, eye drops, and ointments manufactured in India. Countries such as the Gambia, Uzbekistan, and Cameroon have linked the deaths of 70, 18, and six children, respectively, to cough syrups contaminated in India.

Taking into consideration the above facts reported during the last 16-17 years, one has to think about whether it is advisable to force doctors to write generic medicine. Or it will be in the interest of citizens to control the costs of all medicines and ensure the quality of the medicines sold in the market? Who will be responsible if a doctor writes a prescription for generic medicine, and the patient suffers because of the toxic contents of the spurious drug? Will the patient not hold the doctor negligent? Do we have a mechanism to evaluate whether medicine consumed by a patient has harmful contents? Will the patient's family and doctor not suffer from inevitable delays in the judiciary when the drug manufacturer is responsible, but nowhere in the picture?

The government must establish a medical tribunal for such cases.