Pharma industry seeks clarification on revised MHA guidelines for extended lockdown

The industry is wary of the penal provisions stated in the revised MHA order if certain conditions of operations are not met

The pharma industry has sought clarification on an order issued on April 15, 2020, by the Ministry of Home Affairs (MHA), Government of India. The order comprises consolidated revised guidelines with regards to penal provisions, for ministries/ departments of the Government of India, State/UT authorities on the measures for containment of COVID-19 in the country during the extended lockdown until May 3, 2020.

It mentions that any person violating the given guidelines will be liable to be proceeded against as per the provisions of Section 51 to 60 of the Disaster Management Act 2005, besides legal action under Section 188 of the IPC, and other legal provisions as applicable, will be punished. However, the consolidated revised guidelines will not apply in containment zones, as demarcated by State/UTs/District administrations.

The order also explains that where an offence under this Act has been committed by a company, and it is proved that the offence was committed with the consent or connivance of, or is attributable to any neglect on the part of any Director, Manager, Secretary or other officer of the company, such Director, Manager, Secretary or other officer shall also, be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

The industry is wary of the penal provisions stated in the MHA order since it several Micro, Small and Medium Enterprises (MSMEs) are unable to make arrangements for the stay of workers within their premises, as directed.

As per the order, manufacturing units and other industrial establishments with access control in Special Economic Zones (SEZ) and Export Oriented Units (EoU), industrial estates and industrial townships need to make arrangements for stay of workers within their premises as far as possible and or adjacent buildings and for implementation of standard operating procedures (SOPs) as referred in para 21 (II). The transportation of workers to the workplaces shall be arranged by the employers in dedicated transport by ensuring social distancing.

Expressing the industry’s concerns, Dr Dinesh Dua, Chairman, Pharmexcil said, “There is a lot of confusion over the recent consolidated, revised guidelines issued by the MHA. The order is being interpreted differently among states, districts and even in towns. The guidelines were issued for the purpose of restarting industries in Green and Orange zones, but due to its penal provision, companies are a bit hesitant to continue operations.”

He also informed that the given guidelines about making arrangements for workers are manageable for big players to a certain extent, but the MSMEs may not be able to do so due to the adverse impact of COVID-19. The industry is already facing several issues and many workers are join work. Even if some of them agree, they ask for double or even triple wages. Now, with the penal provision, it will be difficult to operate and its repercussions would be a shortage of medicines in the market.

“The government needs to work out some short term as well as long term plans to deal with this situation during COVID-19, as pharma is a well-regulated industry and follows SOPs strictly,” Dr Dua added.

Vinod Kalani, President, Rajasthan Pharmaceutical Manufacturers Association, (Jaipur) and Working President, Federation of Pharma Entrepreneurs (FOPE) said, “The industry is already performing at high risks and with the limited manpower strength. The penal provision will make it difficult for the pharma industry to ensure a continuous supply of medicines in the market.”

Kalani also pointed out that approximately 80 per cent of COVID-19 cases are asymptomatic. So, even after following the stated norms of social distancing and sanitation within the pharma units’ premises, it will be difficult to ensure that the workers don’t get in touch with any COVID-19 positive patients since they might be interacting with someone for their day-to-day needs, off the work premises. Hence the penal provision should be removed from the guidelines and more clarity should be provided to essential supplies and commodities providers.

Recently, Baroda-based Nandesari Industries Association had written a letter to the State Collector officer informing about four pharma units that have discontinued operations due to the stringent and unmanageable guidelines issued by the MHA. Babubhai Patel, Chairman, Nandesari Industries Association, said, “A worker can get infected anywhere or he might not show the symptoms when the industry restarts and can show symptoms later on, which is not a fault or caused by the industry. These are too harsh penalties. Industrialists should not be treated as criminals. We communicated all our concerns to the authority and they have asked us to give an undertaking mentioning that the industries will maintain a logbook of sanitisation activities in the factory premises, and we have agreed to that fact. However, we have clearly mentioned that no staff will be allowed in our units, and will be resuming the production activities.”

There are around 250 units operating in GIDC, Nandesari. Around 25-30 units are involved in supplying various materials, mainly chemicals and solvents to pharma companies.

Commenting on the issue, Viranchi Shah, National Vice President, Indian Drug Manufacturers’ Association said, “The Indian pharma industry has been working all through the lockdown, ensuring that essential medicines are available.  The government has been always supportive of enabling this industry to work seamlessly. However, there seems to be some confusion over the penal provisions as per the MHA’s latest order on conditions of operations for industries. A clarification on this can instil confidence in the minds of the industry that is putting all efforts to run their units under adverse conditions.”

He also informs that the Gandhinagar collector has already issued an order which clarifies the confusion over penal charges, however, Ahmedabad-based pharma units also need clarification.

The Uttarakhand Drugs Manufacturers Association has also written a letter to the State Health Secretary expressing the industry’s concerns over penal provision mentioned in the MHA Order. Sanjay Sikaria, Secretary, Uttarakhand Drugs Manufacturers Association said, “The MHA’s revised set of rules has some very harsh provisions that hold the company directors and management accountable for any employee testing positive for COVID-19. It directs district authorities to take action under the Disaster Management Act against companies for not just non-compliance with safety measures but also for any incidence of COVID-19 at workplaces, including FIRs and action for criminal negligence”

He explains, “More than 3/4th of the COVID-19 positive cases, which are found in India are asymptomatic. Despite all precautions taken by the industry, how can one rule out an infected person who is asymptomatic? Especially if a carrier of the virus reports for work and is himself unaware about the infection? Hence, on behalf of the industry, we have written a letter to the State Secretary requesting to take suitable action so that the pharma industry is not harassed and grant suitable protection from harsh penal provisions.”

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