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Crackdown on Corruption in FDA in India – Key takeaways from recent developments

Two separate incidents, one relating to India’s central drug law enforcement body- the Central Drugs Standards Control Authority (CDSCO), and another relating to a State drugs law enforcement body- the Himachal Pradesh Drugs Control Administration (HPDCA), have received widespread attention. On August 16 2019, a very senior officer of the CDSCO was arrested while accepting a bribe.  On August 23 2019, the residential and office premises of a very senior officer of HPDCA was raided by the vigilance department on bribery allegations. These high profile investigations closely follow the arrest of a Drug Inspector of CDSCO and the Managing Director of a Pharmaceutical Company on grounds of hatching an alleged conspiracy to ‘manage’ adverse results of a government lab test. All these individuals have been charged for commission of offences under India’s anti-bribery law i.e. The Prevention of Corruption Act, 1988.

The official communication from the Central Government with respect to the arrest of its officer reads: “All stakeholders, public and officers shall take cognizance of the fact that CDSCO has the policy of zero tolerance towards corruption and is committed to act stringently against any act of corruption.”

The official communication is very interesting, especially in the background of the reported facts that prompted the arrests.

The complaint against the senior officer of the HPDCA was that he was allegedly receiving “undue favours” such as free air tickets and hotel accommodation from pharmaceutical companies.

The complaint against the Drug Inspector of CDSCO was that he had allegedly demanded a bribe to ignore the deficiency in samples of dobutamine injection. The drug is used to treat acute heart failure

It is not unusual in India for individuals from different verticals of pharmaceutical / medical device business – quality, regulatory, government affairs and senior management, to actually be in direct and repeated contact with officers of the drugs law enforcement bodies for genuine business reasons.

It may not be right to say that such constant interaction is a bad thing. However, it does increase the possibility of corruption. Therefore, it is important to sensitize those in direct contact with government officers that-

  1. It is a criminal offence not just to demand or take a bribe, but also to offer or give a bribe in India.
  2. A bribe does not necessarily have to be in cash. It may be in kind as well such as by way of flight tickets, hotel stays or expensive liquor bottles.
  3. MNCs doing business in India are at higher risk of corruption because, as subsidiaries of US or UK holding companies, they expose the holding companies to the risk of violation of stringent foreign anti-bribery laws such as US Foreign Corrupt Practice Act and UK Bribery Act.

Some important take-aways from the recent crack-down on corruption in the drug enforcement bodies –

  1. The degree of vigilance by CDSCO and other state-level enforcement bodies i.e. State FDAs against corruption has increased. According to reports, a “zero tolerance” policy against corruption has been put in place.
  2. The Managing Director of a pharmaceutical company was arrested along with the Inspector of CDSCO for paying the bribe even though he was not physically present when the bribe was accepted. Therefore, the senior management of a company is especially exposed to an anti-bribery prosecution since they are in charge of day to day operations of the company.
  3. Doing a favour to a government officer, like booking flight ticket or hotel accommodation or providing free medicines/medical devices, may be looked at as an instance of bribe both under Indian and foreign laws.
  4. It is reported that the complaint against HPDCA officer was done by a pharmaceutical company. While it is up to the Courts to establish the veracity of the complaint, it does show that there is scope for refusing a demand of a bribe and for lodging an effective complaint.

Last but not the least, these developments underscore the importance to put in place appropriate systems and processes that act as a risk mitigation tool against the possibility of corruption. At the very minimum, every pharmaceutical and medical device company should have a written policy on corrupt practices that is both comprehensive and practical to suit the reality of India. This must be complemented by regular training sessions to communicate the policy to everyone in the company in a language that they will understand. Some companies have already put in place a whistle-blower policy. The policy must be fine-tuned to escalate potential acts of corruption as well.

Better safe than sorry!

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Ethical marketing and promotion of medicines

Time and again, the pharmaceutical industry has been accused of indulging in unethical practices concerning the marketing of medicines around the world.  These unethical marketing practices are, in fact, a major area of concern for the Government as well as patient groups. Amongst all unethical practices, the one that attracts the highest amount of scrutiny is the (questionable) interaction between pharmaceutical companies and healthcare practitioners (HCPs).

India is no exception. The Draft Pharmaceutical Policy, 2017 published by the Government itself makes a note that unethical practices employed by pharma companies are an area of major concern and that Doctors are lured to recommend a particular brand through all expenses paid trips often disguised as ‘educational conventions’. Unfortunately, the cost of such trips and other incentives gets added to the overhead cost of marketing of the medicine and is ultimately passed on to the patients.

There is no law at present that regulates the promotion and marketing of drugs (including medical devices) by companies before HCPs. Interactions between pharma companies and HCPs are regulated, at best, by way of restrictions cast on HCPs through their respective professional and ethical guidelines. For example, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 regulate the professional and ethical conduct of doctors practising modern medicine and prohibits doctors from accepting any kind of freebies (including travel and accommodation) from pharma and allied healthcare industry. Unfortunately, the principal legislation that regulates the pharma industry i.e. The Drugs and Cosmetics Act, 1940 does not say what pharma companies can and cannot say, or give or cannot give, to HCPs.

It is true that there are consumer protection legislations in India such as the Consumer Protection Act, 1986 (now the Consumer Protection Act, 2019) and the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules, 1955 but these legislations regulate misleading advertisements, not unethical industry-HCP interaction.

It is, perhaps, not right to say that the government has turned a blind eye to this problem. In fact, in light of the increasing number of complaints of unethical practices adopted by pharma companies, the Department of Pharmaceuticals had introduced the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) back in 2011 (later revised in 2014). The intent behind UCPMP code was to guide the pharma industry in its interaction with HCPs. However, the voluntary nature of UCPMP has relegated its own status to that of a “non-binding guideline”.

However, not all is lost. There is no dearth of pharma companies who are proudly ethical in their dealings with HCPs. In fact, most pharma MNCs have put in place exhaustive internal guidelines and robust internal systems which guide interactions of their medical representatives/marketing personnel with HCPs.  Interestingly, HCPs also seem to value such ethical behaviour. It is obvious that, at the end of the day, a HCP will prescribe medicines from only those pharma companies whose quality he or she trusts.

It is quite likely that the Indian government may decide to give legal teeth to UCPMP and make it binding. After all, the UCPMP is the nearest Indian equivalent to the US Physicians Payment Sunshine Act that we have. Interestingly, the enforcement of the Sunshine Act by US Authorities have resulted in hundreds of millions of dollars in fines for some pharma companies.

There is no doubt that making UCPMP into a law would certainly help to curb the rampant quid-pro-quo arrangements that exist today between pharma companies and HCPs. More so, those companies which currently engage in unethical practices will be forced to re-evaluate their sales and marketing strategies and become compliant, or else they will have to face legal consequences.  

In the meanwhile, at least those companies who have achieved leadership positions in India’s pharma industry may lead by example and assume voluntary responsibility to follow UCPMP in text and spirit. The pharma industry associations would also do much good if they could adopt the UCPMP and direct their members to ensure compliance with the provisions of UCPMP at all costs. Such proactiveness will go a long way in instilling a sense of confidence amongst the Government and patients groups. And if that happens, needless to say,  the heavily regulated industry that is pharma industry will have one less regulation to worry about.

The views are personal.

Anil Upadhyay